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THE MINISTRY OF HEALTH
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THE SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
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No. 18/2019/TT-BYT
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Hanoi, July 17, 2019
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CIRCULAR
GUIDELINES ON GOOD MANUFACTURING
PRACTICES (GMP) FOR HEALTH SUPPLEMENTS
Pursuant
to the Law on Food Safety dated June 17, 2010;
Pursuant
to the Government’s Decree No. 15/2018/ND-CP dated February 02, 2018 on
elaboration of some Articles of the Law on Food Safety;
Pursuant
to the Government’s Decree No. 75/2017/ND-CP dated June 20, 2017 defining the
functions, tasks, powers and organizational structure of the Ministry of
Health;
At the
request of the Director of the Vietnam Food Administration,
The
Minister of Health hereby promulgates a Circular to provide guidelines on Good
Manufacturing Practices (GMP) for health supplements.
Article 1. Scope
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1.
Principles and requirements of Good Manufacturing Practices (GMP) for health
supplements and application of GMP by domestic manufacturers of health
supplements.
2. Certificates
equivalent to the Certificate of compliance with GMP for imported health
supplements.
Article 2. Regulated entities
This
Circular applies to organizations and individuals that manufacture or sell health
supplements in Vietnam and other relevant organizations and individuals.
Article 3. Principles and requirements of GMP for health
supplements and application of GMP by domestic manufacturers of health
supplements
1. Domestic manufacturers of health supplements shall satisfy
food safety conditions specified in Clause 1 Article 28 of the Government’s
Decree No. 15/2018/ND-CP dated February 02, 2018 on elaboration of some
Articles of the Law on Food Safety and the following principles and
requirements of GMP for health supplements :
a) Health supplements are manufactured in such a way that
they are fit for their intended use, comply
with the requirements of the marketing authorization and do not place patients
at risk due to inadequate safety, quality or efficacy. To achieve the quality
objective reliably, there must be a comprehensively designed and correctly
implemented system of quality assurance incorporating GMP and quality control.
It should be fully documented and its effectiveness monitored. All parts of the
quality assurance system should be adequately staffed with competent personnel,
and should have suitable and sufficient premises, equipment, and facilities;
b) Every
manufacturer should have an adequate number of personnel with the necessary qualifications
and practical experience relevant to their assigned function. Staff at all
levels should receive initial training and periodic training in GMP principles
and for the tasks and responsibilities assigned to them;
c)
Premises and manufacturing equipment must be located, designed, constructed,
adapted and maintained to suit the operations to be carried out. The layout and
design of premises must aim to minimize the risk of errors and permit effective
cleaning and maintenance in order to avoid cross-contamination, build-up of
dust or dirt, and in general, any adverse effect on the quality of products;
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dd) Every manufacturer should establish a system of clearly
written documentation that consists of procedures, standards, manufacturing
formulae, processing and packaging instructions, is able to record executed
activities for manufacturing, quality control, distribution and other matters
linked to GMP, and permits tracing of batch history of the product, from
receiving of starting materials to the distribution of finished products.
e) There
must be an authorized manufacturing process existing for each product,
including detailed regulations on manufacturing and quality control, with the
objective of obtaining a product of the requisite quality, consistent with the
approved specifications. Executed activities for each batch should be
sufficiently and clearly documented and retained as prescribed;
g) Every
manufacturer should have a quality control system so designed as to ensure that
the production and the quality control departments are independent of each
other and that the products are manufactured in accordance with adequate
conditions and procedures and continue to meet the established specifications;
h) If a
product is manufactured and/or analyzed under a contract, the contract
manufacture and/or analysis must be correctly defined, agreed and controlled.
The contract must clearly establish the duties and responsibilities of each
party and clearly state the way in which the authorized person releasing each
batch of product for sale exercises his full responsibility.
i) All
complaints and other information concerning potentially defective products must
be kept and reviewed according to written procedures. A system shall be
designed to recall promptly and effectively products known or suspected to be
defective from the market.
k)
Self-inspections shall be conducted in order to monitor the implementation and
compliance with Good Manufacturing Practice principles and to propose necessary
corrective measures.
l)
Detailed contents of GMP for health supplements are provide in the Appendix
hereof.
2. Any manufacturer of herbal ingredients and semi-finished
herbal ingredients that has been issued with the effective Certificate of
compliance with GMP for herbal ingredients and semi-finished herbal ingredients
in the form of glue, granule, powder, extract, essential oil, resin, gum and
jelly by the Drug Administration of Vietnam - the Ministry of Health or the
Traditional Medicine Administration of Vietnam - the Ministry of Health in
accordance with regulations of law on pharmacy is entitled to manufacture raw
materials and semi-finished health supplements whose dosage forms are
equivalent to those that have been certified and is not required to apply for
issuance of the Certificate of compliance with GMP for health supplements.
3. Any manufacturer of herbal medicinal products and
traditional medicinal products that has been issued with the effective Certificate
of compliance with GMP for herbal medicinal products and traditional medicinal
products by the Drug Administration of Vietnam - the Ministry of Health or the
Traditional Medicine Administration of Vietnam - the Ministry of Health in
accordance with regulations of law on pharmacy is entitled to manufacture
health supplements whose dosage forms are equivalent to those that have been
certified and is not required to apply for issuance of the Certificate of GMP
compliance with health supplements. The provisions of this Clause shall come
into force on the effective dates of the legislative documents mentioned in
Clause 2 Article 5 of this Circular.
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1. Imported health
supplements shall be manufactured by a manufacturer that has been granted one
of the following certificates by a competent authority of the manufacturing country (including food safety regulator
or organization designated or acknowledged by the food safety regulator or
another country’s organization acknowledged by the regulatory authority of the
manufacturing country):
a) Certificate of GMP compliance if it is a manufacturer of
health supplements;
b) Certificate of compliance with GMP for herbal medicinal
products and traditional medicinal products whose dosage forms are equivalent
to those of imported health supplements if it is a:
- manufacturer of countries included by the Ministry of
Health in the list of countries which have sign a mutual recognition agreement
on GMP inspections with Vietnam;
- manufacturer of ICH
(International Council for Harmonisation of Technical Requirements for
Pharmaceuticals for Human Use) countries or Australia, which has undergone GMP
compliance inspection by one of the SRAs of the U.S (US Food and Drug
Administration - USFDA), EU countries (European Medicines Agency - EMA),
Australia (Therapeutic Goods Administration - TGA), Japan
(Pharmaceuticals and Medical Devices Agency - PMDA) or Canada (Health Canada);
- Other manufacturers, which have been recommended by the
Drug Administration of Vietnam - the Ministry of Health or the Traditional
Medicine Administration of Vietnam - the Ministry of Health to make the
declaration of compliance with GMP.
The provisions of this Clause shall come into force on the
effective dates of the legislative documents mentioned in Clause 2 Article 5 of
this Circular.
c) Regarding the countries or territories that do not issue
the certificates specified in Points a and b of this Clause, it is required to
confirm manufacturers’ compliance with requirements and conditions for
manufacturing of health supplements or herbal medicinal products and
traditional medicinal products in writing or publish the compliance on the
official website of the competent authority of such countries or territories;
d) Regarding the countries or territories that do not issue
the certificates or provide confirmation as prescribed in Points a, b and c of
this Clause, the Ministry of Health shall establish an Expert Committee,
including a head of the Vietnam Food Administration - the Ministry of Health;
representative of the Drug Administration of Vietnam - the Ministry of Health;
representative of the Traditional Medicine Administration of Vietnam - the
Ministry of Health; representative of the Department of Legal Affairs - the
Ministry of Health; representative of the Department of International
Cooperation - the Ministry of Health and experts in appropriate field if necessary.
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2. A certificate or equivalent certificate mentioned in
Points a, b and c Clause 1 of this Article shall contain:
a) Name of the issuing authority;
b) Date
of issue;
c)
Expiration date (if the expiration date is not written on the certificate,
documents including an assessment report or periodic inspection record are
required to prove that the manufacturer still maintains its fulfillment of food
safety conditions);
d) Full
name and signature of the person issuing the certificate;
dd) Name and address of the certificate holder;
e) Scope covered by the certificate;
g) Dosage form or name of the product certified.
Article 5. Effect
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2. The provisions of Clause 3 Article 3 and Point b Clause 1
Article 4 of this Circular shall come into force on the dates on which relevant
legislative documents are amended, promulgated and effective, allowing
manufacturing of health supplements on the line intended for the manufacturing
of herbal medicinal products and traditional medicinal products.
Article 6. Transitional clauses
1.
Regarding domestically manufactured or imported health supplements issued with
the Certificate of Declaration of conformity with food safety regulations or
Certificate of registered product declaration that remains effective but not
issued with the Certificate of compliance with GMP for health supplements or an
equivalent certificate as prescribed in this Circular:
a) The
products manufactured before July 01, 2019 shall be sold until their expiration
date;
b) From
July 01, 2019, every organization and individual shall submit a copy
(authenticated by the health supplement manufacturer) of the Certificate of
compliance with GMP for health supplements or equivalent certificate as
prescribed in this Circular prior to manufacturing.
2. Applications for registration of the health supplement
declaration submitted before July 01, 2019 (including those submitted before
July 01, 2019 and revised after July 01, 2019) shall be processed as prescribed
in Article 8 of the Government’s Decree No. 15/2018/ND-CP .
Article 7. Responsibility for implementation
1. The
Vietnam Food Administration shall:
a) take
charge and cooperate with relevant units in disseminating, providing guidance
and implementing this Circular;
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c)
cooperate with the Drug Administration of Vietnam, Traditional Medicine Administration of Vietnam and Inspectorate of the
Ministry of Health in inspecting the compliance with principles and
requirements of GMP for health supplements by
manufacturers of herbal ingredients, semi-finished herbal ingredients, herbal
medicinal products and traditional medicinal products that have been issued
with the Certificate of eligibility for pharmacy business or Certificate of
compliance with GMP for medicinal products and medicinal materials.
2. The
Drug Administration of Vietnam and Traditional Medicine Administration of
Vietnam shall, within their jurisdiction, take charge or cooperate with the
Vietnam Food Administration in inspecting the compliance with principles and
requirements of GMP for health supplements by manufacturers of herbal
ingredients, semi-finished herbal ingredients, herbal medicinal products and
traditional medicinal products that have been issued with the Certificate of eligibility
for pharmacy business or Certificate of compliance with GMP for medicinal
products and medicinal materials, which allows manufacturing of health
supplements.
3.
Organizations and individuals that manufacture or sell health supplements
shall:
a) comply
with regulations of this Circular;
b)
maintain their compliance with principles and requirements of GMP for health
supplements according to the Certificate of compliance with GMP for health
supplements or the equivalent certificate that has been granted and
acknowledged throughout their operations.
4. The Director of the Vietnam Food Administration, Chief of
the Ministry Office, Chief Inspector of the Ministry of Health, Directors and
General Directors of Departments and General Departments affiliated to the
Ministry of Health and relevant organizations and individuals are responsible
for the implementation of this Circular.
Difficulties
that arise during the implementation of this Circular should be reported to the
Ministry of Health (Vietnam Food Administration) for consideration./.
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APPENDIX:
PRINCIPLES AND REQUIREMENTS
OF GMP FOR HEALTH SUPPLEMENTS
(Enclosed with the Circular No. 18/2019/TT-BYT dated July 17, 2019 of
the Minister of Health)
Acronyms
Glossary
I.
Quality management
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Principle
Quality
assurance
Quality
control
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II.
Personnel
Principle
Organization,
qualification and responsibilities
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Training
III.
Premises and equipment
Principle
Premises
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General
Production
areas
Storage
areas
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Quality
control areas
Ancillary
areas
Equipment
IV.
Sanitation and hygiene
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Principle
Personnel
Premises
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Equipment
and utensils
V.
Documentation
Principle
General
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Quality
control documents
Specifications
Specifications
for natural materials
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Specifications
for starting materials and packaging materials
Specifications
for intermediate and bulk product
Specifications
for finished products
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Manufacturing
formula and Processing instructions
Packaging
Instructions
Batch
processing records
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Batch packaging
records
Standard
Operating Procedures (SOPs) and records
VI.
Production
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General
Verification
Prevention
of cross-contamination in production
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Starting
materials
Processing
operations: Intermediate and bulk products
Packaging
materials
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Packaging
operations
Finished
products
Rejected,
recovered and returned materials
VII.
Quality control
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Principle
General
Sampling
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Testing
Ongoing
stability programme
VIII.
Contract manufacture and analysis
Principle
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Contract
manufacture
Contract
analysis
The
contract giver
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The
contract acceptor
The
contract
IX.
Complaints and product recalls
Principle
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Product
complaints
Product
recalls
Complaints
on adverse product reactions
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Principle
XI.
Other contents:
List of
internationally accepted references for test methods
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Verification
Guidelines
on stability study and shelf-life of health supplements
Self-inspection
questionnaire
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Acronyms:
1. ASEAN:
Association of South East Asian Nations
2. ATTP:
An toàn thực phẩm (“Food safety”)
3. FEFO:
First Ended, First Out
4. FEFO:
First In, First Out
5. GMP:
Good Manufacturing Practice
6. HEPA:
High Efficiency Particulate Air
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□ Air
ventilation
□
Temperature and humidity control
□ Dust
filtration (if required)
8. NRA:
National Regulatory Authority
9. QA:
Quality Assurance
10. QC:
Quality Control
11. SOP:
Standard Operating Procedure
12. VAFF:
Vietnam Association of Functional Food.
13. WHO:
World Health Organization
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Glossary
For the
purposes of this Appendix, the terms below shall be construed as follows:
1.
Bulk
product: Any product that has completed all processing stages up to, but not
including, final packaging.
2.
Packaging:
Any packaging of food, whether by way of completely or partially enclosing
the food and has the following types of packaging:
- Consumer
packaging, which is directly attached to goods and sold together with goods
to consumers, and include:
+
Primary packaging, which is designed to contain goods, comes into direct
contact with goods, shapes goods or encloses goods in the shape of goods.
+
Secondary packaging, which is designed to contain one or more primary
packaging materials together.
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3.
Quarantine or separation: The
status of starting materials, intermediate, bulk and finished products set
apart physically or by system while awaiting a decision on their suitability
for processing, packaging, distribution, reprocessing or rejection.
4.
National
Regulatory Authority: It is the country regulatory authority which exercises
a legal right to control the import, manufacture and export and which may
take regulatory action to ensure that the health supplement products marketed
within its jurisdiction comply with regulatory requirement.
5.
Qualification:
Action approving and documenting the equipment or ancillary systems are
properly installed, work correctly and actually lead to expected results.
6.
Packaging:
All operations, including filling and labeling, that a bulk product has to
undergo in order to become a finished product.
7.
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8.
Expiry
Date: A date fixed for each individual batch before which the batch still
meets the required standard specifications for quality. After this date, the
batch is not permitted for sale.
9.
Sanitation:
Hygienic control on manufacturing processes, including personnel, premises,
equipment and handling of materials from starting materials to finished
products.
10.
Documentation:
Any document that shows results obtained or provides evidence of the
activities performed.
11.
Control:
Any necessary activity performed to ensure maintenance of standards specified
in the manufacturing process.
12.
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13.
Batch
(or Lot): A quantity of any health supplement produced during a given cycle
of manufacture and from a specific formulation order, that is uniform in
character and quality (the essence of a manufacturing batch is its
homogeneity).
14.
Rejected:
The status of starting materials, intermediate, bulk or finished products
which are not permitted to be used for processing, packaging or distribution
and shall be discarded in a safe manner.
15.
Reference
sample: A sample is representative of the batch of starting/packaging
materials or intermediate/finished products from which they are taken, stored
for the purpose of being analyzed shall the need arise during the shelf life
of the batch concerned.
16.
Hazard:
A biological, chemical or physical agent in a food with the potential to
cause an adverse health effect.
17
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18.
Authorized
Person: A person who is formally and properly empowered and has the authority
to perform specified duties associated with the company.
19.
Risk: The
chance or (probability) that a hazard will occur.
20.
Starting
Materials: Any substance or mixture of substances (pre-mix) used in the
production of a health supplement excluding packaging material.
21.
Raw
Materials: All materials whether active or inactive that are employed in the
processing of health supplements.
22.
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23.
Natural
Materials: Comminuted or powdered natural materials, extracts, tinctures,
fatty or essential oils, resins, gums, balsams, expressed juices, etc.
prepared from plant, animal or mineral, and preparations whose production
involves a fractionation, purification or concentration process, excluding
chemically defined isolated constituents.
24.
Contamination:
The introduction of any foreign matter (food contaminants may be biological,
chemical or physical agent) into a food.
25.
Product:
The result of a process or of a set of activities that are interrelated or
that interact with one another.
26.
Intermediate
Product: Any material or mixture of materials which have to undergo one or
more stages of processing to become a bulk or finished product.
27.
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28.
Reprocessing:
A method of repeating the process of all or part of a batch with an
unacceptable quality to undergo special or additional processing before
release.
29.
Finished
Product: A product which has undergone all the stages of manufacture,
including packaging in its final container and labeling.
30.
Verification:
Confirmation, through the provision of objective evidence, that the
requirements for any procedure, process, equipment, material, activity or
system have been fulfilled.
31.
Product
Recall: It is an action taken to remove a product from the market. Recalls
maybe initiated by the NRA or a voluntary action on the part of manufacturer
and distributor to carry out their responsibility to protect the public
health and well-being from products that present a risk of injury or gross
deception or are otherwise deceptive.
32.
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a.
Vitamins, minerals, amino acids, fatty acids, enzymes, probiotics and other
bioactive substances.
b.
Substances derived from natural sources, including animal, mineral and
botanical materials in the forms of extracts, isolates, concentrates, metabolite.
c.
Synthetic sources of ingredients mentioned in (a) and (b).
It
is presented in dosage forms (to be administered) in small unit doses such as
33.
Packaging
Materials: Any material, including printed material, employed in the packaging
of a health supplement, such as containers, closures, bags, packing, label
materials, seals, binding materials, adhesives and tapes.
34.
Released
or Passed: The status of starting materials, intermediate, bulk or finished
products which are allowed to be used for processing, packaging or
distribution.
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Principle
Health
supplements shall be manufactured so as to ensure that they are fit for their
intended use, comply with the requirements of the National Regulatory Authority
(NRA) and do not place the health of the patients or consumers at risk due to
inadequate safety and quality. The attainment of this quality objective is the
responsibility of senior management and requires the participation and
commitment of staff in many different departments and at all levels within the
company, by the company’s suppliers and by the distributors. To achieve the
quality objective reliably, there must be a comprehensively designed and
correctly implemented system of quality assurance incorporating GMP and quality
control. It shall be fully documented and its effectiveness monitored. All
parts of Quality Assurance system shall be adequately resourced with competent
personnel, suitable and sufficient premises, equipment and facilities.
1.1. The
basic concept of Quality Assurance, Good Manufacturing Practice and Quality
Control are inter-related. They are described here in order to emphasize their
relationships and their fundamental importance to the production and control of
health supplements.
Quality
assurance
1.2.
Quality Assurance is a wide-ranging concept which covers all matters which
individually or collectively influence the quality of a product. It is the sum
total of the organized arrangements made with the object of ensuring the products
are of the quality required for their intended use. Quality assurance therefore
incorporates Good Manufacturing Practice plus other factors outside the scope
of these guidelines.
The
system of Quality Assurance appropriate for the manufacture of health
supplements shall ensure that:
1.2.1.
Health supplements are designed and developed in a way that takes account of
the requirements of GMP.
1.2.2.
Production and control operations are clearly specified and GMP adopted.
1.2.3.
Managerial responsibilities are clearly specified.
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1.2.5.
All necessary controls on starting materials, intermediate products, and bulk
products and other in-process controls, calibrations and validations are
carried out.
1.2.6.
The finished product is correctly processed and checked, according to the
defined procedures.
1.2.7.
Health supplements are not sold or supplied before a head of Quality Control
has certified that each production batch has been produced and controlled in
accordance with the marketing authorization and any other procedures relevant
to the production, control and release of health supplements.
1.2.8.
Satisfactory arrangements exist to ensure, that the health supplements are
stored, distributed and subsequently handled so that quality is maintained
throughout their shelf life.
1.2.9.
There is a procedure for self-inspection and/or quality audit, which regularly
appraises the effectiveness and applicability of the Quality Control system.
1.3. Good
Manufacturing Practice is that part of Quality Assurance which ensures that
products are consistently manufactured and controlled to the quality standards
appropriate to their intended use and as required by the marketing
authorization or product specification. Good Manufacturing Practice is
concerned with both production and quality control. The basic requirements of
GMP are that:
1.3.1.
All manufacturing processes are clearly defined, systematically reviewed in the
light of experience and shown to be capable of consistently manufacturing
health supplements of the required quality and complying with their
specifications.
1.3.2.
Critical steps of manufacturing processes and significant changes to the process
are verified.
1.3.3.
All necessary facilities are provided, including:
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1.3.3.2.
Adequate premises and space;
1.3.3.3.
Suitable equipment and services;
1.3.3.4. Appropriate
materials, containers and labels;
1.3.3.5.
Approved procedures and instructions;
1.3.3.6.
Suitable storage and transport.
1.3.4.
Instructions and procedures are written in clear and unambiguous language,
specifically applicable to the facilities provided.
1.3.5.
Operators are trained to carry out procedures correctly.
1.3.6.
Records are made, manually and/or by recording instruments, during manufacture
which demonstrate that all the steps required by the defined procedures and
instructions were in fact taken and that the quantity and quality of the
products as expected. Any significant deviations are fully recorded and
investigated.
1.3.7.
Records covering manufacture and distribution, which enable the complete
history of a batch to be traced, are retained in a comprehensible and
accessible form.
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1.3.9. A
system is available to ensure that any batch of product should be recalled from
sale as soon as possible.
1.3.10.
Complaints about marketed products are examined, the causes of quality defects
investigated and appropriate measures taken in respect of the defective
products and to prevent recurrence. This should be documented.
Quality
control
1.4. Quality
Control is the part of Good Manufacturing Practice concerned with: (i)
Specifications and testing, (ii) Sampling and (iii) Tests carried out in
accordance with regulations, and with the organization, documentation and
release procedures which ensure that the necessary and relevant tests are
actually carried out and that materials are not released for use, nor products
released for sale or supply, until their quality has been judged to be
satisfactory.
The basic
requirements of Quality Control are that:
1.4.1.
Adequate facilities, trained personnel and approved procedures are available
for sampling, inspecting and testing starting materials, packaging materials,
intermediate, bulk, and finished products, and where appropriate for monitoring
environmental conditions for GMP.
1.4.2.
Samples of starting materials, packaging materials, intermediate products, bulk
products and finished products must be taken by methods and personnel approved
of by the quality control department.
1.4.3.
Test methods are either internationally accepted or other validated methods
(refer to Section 11.1).
1.4.4.
Records must be made (manually and/or by recording instruments) demonstrating
that all the required sampling, inspecting and testing procedures have actually
been carried out and that any deviations have been fully recorded and
investigated;
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1.4.6.
Records must be made of the results of inspecting and testing the materials and
intermediate, bulk and finished products against specifications. Product
assessment must include a review and evaluation of the relevant production
documentation and an assessment of deviations from specified procedures.
1.4.7. No
batch of product is to be released for sale or supply prior to certification by
the authorized person(s) that it is in accordance with the requirements of the
marketing authorization.
1.4.8.
Sufficient samples of starting materials and products must be retained to
permit future examination of the product if necessary; the retained product
must be kept in its final pack unless the pack is exceptionally large.
Product
quality review
1.5.
Regular periodic or rolling quality reviews of all health supplements,
including export only products, shall be conducted with the objective of
verifying the consistency of the existing process, the appropriateness of
current specifications for both starting materials and finished product to
highlight any trends and to identify product and process improvements. Such
reviews shall normally be conducted and documented annually, taking into
account previous reviews, and shall include at least:
1.5.1. A
review of starting materials and packaging materials used for the product,
especially those from new sources;
1.5.2. A
review of critical in-process controls and finished product results;
1.5.3. A
review of all batches that failed to meet established specification(s) and
their investigation;
1.5.4. A
review of all significant deviations or non -conformances, their related
investigations, and the effectiveness of resultant corrective and preventative
actions taken;
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1.5.6. A
review of product authorization variations (submitted/granted/ refused),
including those for third country (export only) dossiers;
1.5.7. A
review of the results of the stability monitoring programme and any adverse
trends;
1.5.8. A
review of all quality-related returns, complaints and recalls and the
investigations performed at the time;
1.5.9. A
review of adequacy of any other previous product process or equipment
corrective actions;
1.5.10.
The qualification status of relevant equipment and utilities, e.g. Heating,
Ventilation and Air Conditioning (HVAC), water, compressed gases, etc.;
1.5.11. A
review of Contractual Agreements to ensure that they are up to date;
1.5.12. A
review of post-marketing commitment for new product/variation.
1.6. The
manufacturer and manufacturing authorization holder shall evaluate the results
of this review and an assessment shall be made whether corrective and preventive
action shall be undertaken. Reasons for such corrective actions shall be
documented. Agreed corrective and preventive actions shall be completed in a
timely and effective manner. There shall be management procedures for the
ongoing management and review of these actions and the effectiveness of these
procedures verified during self-inspection. Quality reviews may be grouped by
product type, e.g. solid dosage forms, liquid dosage forms, etc. where
scientifically justified.
1.7.
Where the product owner is not the manufacturer, there shall be a technical
agreement/contract in place between the various parties that defines their
respective responsibilities in producing the quality review. The authorized
person responsible for final batch certification together with the product
owner shall ensure that the quality review is performed in a timely manner and
is accurate.
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Principle
The
establishment and maintenance of a satisfactory system of quality assurance and
the correct manufacture and control of pharmaceutical products and active
ingredients rely upon people. For this reason, there shall be an adequate
number of personnel with the necessary qualifications and practical experience
relevant to their assigned function. The responsibilities placed on any one
individual should not be so extensive so as to present any risk to quality.
Staff at
all levels should receive initial and continuing training in the principles of
GMP and for the tasks and responsibilities assigned to them so that they have
the attitudes for achieving the goals of Good Manufacturing Practice.
Organization,
qualification and responsibilities
2.1. The
manufacturer shall have an organization chart. People in responsible positions
shall have specific duties recorded in written job descriptions and adequate
authority to carry out their responsibilities. There shall be no gaps or
unexplained overlaps in the responsibilities of those personnel concerned with
the application of Good Manufacturing Practice. Key personnel include the head
of Production Department and the head of Quality Control Department (or
including the head of Production Department, head of testing department and
head of quality assurance department). Key posts should be occupied by
full-time personnel having knowledge, skill and capabilities relevant to their
assigned function, and capable of handling their duties properly. The heads of
production and quality control departments should be independent of each other.
In large organizations, it may be necessary to delegate some of the functions
(mentioned in sections 2.2, 2.3 and 2.4 below); however, the responsibility
cannot be delegated.
2.2. The
head of Production Department shall have full authority and responsibilities to
manage production of products covering operations, equipment, production
personnel, production area and records.
The head
of the Production Department generally has the following responsibilities:
2.2.1. To
ensure those products are manufactured and stored according to the appropriate documentation
in order to obtain the required quality;
2.2.2. To
approve the instructions relating to production operations, including the
in-process controls and to ensure their strict implementation;
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2.2.4. To
check the maintenance of the department, premises and equipment;
2.2.5. To
ensure that the critical processes are appropriately verified;
2.2.6. To
ensure that the required initial and continuing training of production
personnel is carried out and adapted according to need.
2.3. The
head of Quality Control Department shall have adequate training and practical
experience, which can enable the person to perform the functions effectively.
He/She shall be given full authority and responsibility in all quality control
duties such as establishment, verification and implementation of all quality
control procedures. He/She shall have the sole authority to approve starting
materials, intermediates, bulk and finished products that meet the
specification or to reject those which do not conform to the relevant
specification or which were not manufactured in accordance with approved
procedures and under the defined conditions.
The head
of Quality Control shall have the following responsibilities:
2.3.1. To
approve or reject starting materials, packaging materials and intermediate,
bulk and finished products;
2.3.2. To
evaluate batch records;
2.3.3. To
ensure that all necessary testing is carried out;
2.3.4. To
ensure that the critical processes are appropriately verified;
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2.3.6. To
approve and monitor tests carried out under contract;
2.3.7. To
check the maintenance of the department, premises and equipment;
2.3.8. To
establish expiration date and shelf life specifications on the basis of
stability test or available stability data related to storage conditions;
2.3.9. To
approve those suppliers of raw materials and packaging materials;
2.3.10.
To evaluate all complaints received or deficiencies noted about any batch, if
necessary in conjunction with other departments, and to take appropriate action
accordingly;
2.3.11.
To maintain adequate analytical records concerning the examinations of all
samples taken;
2.3.12.
To recommend contract-manufacturing operations;
2.3.13.
To ensure that the required initial and continuing training of his department
personnel is carried out and adapted according to need.
2.4. The
heads of Production Department and Quality Control Department shall share a
joint responsibility:
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2.4.2. To
monitor and control the manufacturing environment, sanitation and hygiene;
2.4.3. To
verify critical processes;
2.4.4. To
verify critical processes;
2.4.5. To
approve and monitor the suppliers of materials and contract manufacturers;
2.4.6. To
establish and monitor the storage conditions for materials and products;
2.4.7. To
retain records;
2.4.8. To
monitor compliance with the requirements of Good Manufacturing Practice;
2.4.9. To
inspect, investigate and take samples, in order to monitor factors which may affect
product quality.
Training
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2.6.
Training in Good Manufacturing Practice shall be on a continuing basis and with
adequate frequency to assure that employees remain familiar with Good
Manufacturing Practices requirements relevant to their functions. Training in
Good Manufacturing Practice shall be in accordance with written programmes
approved by the head of Production Department and the head of Quality Control
Department.
2.7.
Personnel training records including Good Manufacturing Practice shall be
maintained and the effectiveness of training programmes shall be assessed
periodically.
2.8. The
concept of Quality Assurance and all the measures capable of improving its
understanding and implementation shall be fully discussed during the training
sessions.
III. Premises and equipment
Principle
Premises
and manufacturing equipment must be located, designed, constructed, adapted and
maintained to suit the operations to be carried out. Their layout and design
must aim to minimize the risk of errors and permit effective cleaning and
maintenance in order to avoid cross-contamination, build up of dust or dirt
and, in general, any adverse effect on the quality of products.
Premises:
General
3.1.
Premises for manufacturing shall be of suitable size, design, construction and
location to facilitate proper operation, cleaning and maintenance.
3.2.
Premises shall be carefully maintained, ensuring that repair and maintenance
operations do not present any hazard to the quality of products. They shall be
cleaned and, where applicable, disinfected according to detailed written
procedures.
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3.4.
Lighting, temperature, humidity and ventilation shall be appropriate and such
that they do not adversely affect, directly or indirectly, either the products
during their manufacture and storage, or the accurate functioning of equipment.
3.5.
Premises shall be located at a suitable site approved by the relevant
authorities.
3.6. Premises
shall be situated in an environment which, when considered together with
measures to protect the manufacture, presents minimal risk of causing
contamination of materials or products.
3.7. In
order to minimize the risk of a serious hazard due to cross-contamination,
dedicated and self-contained facilities must be available for the production of
particular products, such as highly sensitizing materials (e.g. penicillins) or
biological preparations (e.g. live microorganisms). The production of other health
supplements should not be conducted in the same facilities. However, sharing of
manufacturing facilities may be considered if the specific precautions are
taken and the necessary validations (including cleaning validation) (refer to
section 6.19) are made to prevent cross-contamination.
3.8.
Premises shall be designed, constructed and maintained to protect against
access and harboring of vermin, rodents, birds, insects or other animals.
3.9.
Design shall consider prevention of mix-up between different products or their
components and the possibility of cross contamination by other substances.
3.10.
Special attention must be given for processing operations that generate dust.
Measures shall be taken to prevent the generation and dissemination of dust.
3.11.
Defined areas for the following operations are required:
3.11.1.
Receiving and quarantine of incoming material;
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3.11.3.
Storage of starting and packaging materials;
3.11.4.
Weighing /Dispensing;
3.11.5.
Processing;
3.11.6.
Storage of bulk/intermediate products;
3.11.7.
Packaging;
3.11.8.
Equipment washing;
3. 11.9.
Storage of quarantine finished products;
3.11.10.
Storage of approved finished products;
3.11.11.
Designated area for quality control.
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Production
areas
3.12.
Where starting and primary packaging materials, intermediate or bulk products
are exposed to the environment, interior surfaces (walls, floors and ceilings)
shall be smooth, free from cracks and open joints, and shall not shed
particulate matter and shall permit easy and effective cleaning and, if
necessary, disinfection. In these areas, the per-cubic-meter particle content
(diameter: ≥ 0.5 μm) should not exceed 3,520,000 and the per-cubic-meter
particle content (diameter: ≥ 5 .0 μm) should not exceed 29,300 under
non-operating conditions. When manufacturing products at high risk of
microbiological contamination (e.g. soft pellets), it is required to define
maximum Colony Forming Units - CFU per volume of air and/or surface area of
equipment in direct contact with the products in the abovementioned areas. The
coving of junctions between walls and floors in the production areas is
encouraged to facilitate cleaning.
3.13. Any
open channels shall be avoided, but if required they shall be shallow enough to
facilitate cleaning and disinfecting. All drainage shall have trapped gullies.
3.14.
Buildings shall be effectively ventilated with air control facilities
(including temperature, humidity and filtration), appropriate both to the
operations undertaken within and to the external environment.
3.15. Production
areas shall be well lit, particularly where visual on-line controls are carried
out.
3.16.
Pipework, light fittings, ventilation points and other services shall be
designed and sited to avoid the creation of recesses which are difficult to
clean. As far as possible, for maintenance purposes, they shall be accessible
from outside the manufacturing areas.
3.17.
Separate areas shall be used for the production of finished products intended
for external use or application and finished products intended for internal
consumption solely.
3.18. In
cases where dust is generated (e.g. during sampling, weighing, mixing and
processing operations, packaging of dry products), specific provisions shall be
taken to avoid cross-contamination and facilitate cleaning.
3.19.
Premises for the packaging of health supplements shall be specifically designed
and laid out so as to avoid mix-ups or cross-contamination.
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3.21.
Adequacy of working space, which shall allow orderly and logical placement of
equipment and materials and to suit the operation, efficient flow of work,
effective communication and supervision.
3.22.
Changing rooms shall be directly connected to but separated from processing
areas.
3.23.
Changing rooms into the production areas shall have adequate hand washing
and/or sanitizing facilities.
Storage
areas
3.24.
Storage areas shall be of sufficient capacity to allow orderly storage of the
various categories of materials and products: starting and packaging materials,
intermediate, bulk and finished products, products in quarantine, released,
rejected or recalled.
3.25.
Storage areas shall be designed or adapted to ensure good storage conditions.
In particular, they shall be clean and dry and maintained within acceptable
temperature limits. Where special storage conditions are required (e.g.
temperature, humidity) these shall be provided, checked and monitored.
3.26.
Segregated and secure areas shall be provided for the storage of rejected,
recalled or returned materials or products. Products rejected during a
manufacturing process should not be stored in the production facility but
marked, recorded in a logbook and returned to stock after each production shift
to prevent mistakes.
3.27.
Highly active materials or products (e.g. flammable, explosive or toxic
substances) shall be stored in separate, safe and secure areas.
3.28.
Receiving and dispatch bays shall protect materials and products from the
weather. Reception areas shall be designed and equipped to allow containers of
incoming materials to be cleaned where necessary before storage.
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3.30.
Printed packaging materials are considered critical to the conformity of the
products, and special attention shall be paid to the safe and secure storage of
these materials.
3.31.
Crude natural materials shall be stored in separate areas. The store area shall
be well ventilated and equipped in such a way as to give protection against
insects, or other animals, especially rodents. Effective measures shall be
taken to prevent the spread of any such animals and microorganisms brought in
with the crude natural materials to prevent cross-contamination. Containers
shall be located in such a way as to allow free air circulation.
3.32.
Special attention shall be paid to the cleanliness and good maintenance of the
storage areas particularly when dust is generated.
3.33.
Storage of plant materials, animal materials including parts, microorganisms,
extracts, tinctures and other preparations that require special conditions of
temperature, humidity or light protection; these conditions shall be provided
and monitored.
Quality
control areas
3.34. If
tests are carried out at production facilities, quality control laboratories,
especially laboratories where microbiological test methods are employed, should
be separated from production areas.
3.35.
Laboratories shall be designed to suit the operations to be carried out in
them. Sufficient space shall be given to avoid mix-ups and cross-contamination.
There shall be adequate suitable storage space for samples and records.
3.36.
Separate rooms may be necessary to protect sensitive instruments from
vibrations, electrical interference, humidity, etc.
3.37.
Special requirements are needed in laboratories handling particular substances
such as microorganism samples.
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3.38.
Rest and refreshment rooms and toilets shall be separated from other areas and shall
not have direct access to controlled areas (e.g. production and storage areas).
3.39.
Facilities for changing clothes, and for washing and toilet purposes shall be
easily accessible and appropriate for the number of users.
3.40. Maintenance
workshops shall be separated from production areas. Whenever parts and tools
are stored in the production area, they shall be kept in rooms or lockers
reserved for that use.
3.41.
Animal houses shall be well isolated from other areas, with separate entrance
and air handling facilities. Warehouses of explosive and flammable substances,
waste storage areas, waste treatment system and boilers (if any) shall be
located far away from production, testing and storage areas in accordance with
safety and hygiene requirements.
Equipment
3.42.
Manufacturing equipment shall be designed, placed and maintained to suit its
intended and ensure safety of employees. The maintenance and replacement of
accessories shall comply with the approved plan and requirements of the
equipment manufacturer.
3.43.
Manufacturing equipment shall be installed so as to prevent contamination or
minimize the risk of error and, where necessary, tested to ensure the equipment
operate appropriately.
3.44.
Manufacturing equipment shall be located at a distance from other equipment
sufficient to avoid congestion and cross contamination.
3.45.
Fixed pipework shall be clearly labeled to indicate the contents and direction
of flow.
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3.47.
Measuring, weighing, recording and control equipment shall be calibrated and
checked at defined intervals by appropriate methods. Adequate records of such
tests shall be maintained.
3.48.
Manufacturing equipment shall be designed so that it can be easily and
thoroughly cleaned. It shall be cleaned according to detailed and written
procedures and stored only in a clean and dry condition.
3.49.
Dedicated equipment used to manufacture products intended for internal
consumption solely shall be separated from equipment used for the manufacturing
of products intended for external use or application.
3.50.
Defective equipment shall, if possible, be removed from production and quality
control areas, or at least be clearly labeled as defective.
3.51.
Repair and maintenance operations shall not present hazard to the quality of
the products. Any missing components such as nuts, springs, clips, etc. shall
be reported and investigated immediately.
3.52.
Production equipment (including transfer pipes and hoses) shall not present any
hazard to the products. The parts of the production equipment that come into
contact with the product must not be reactive, additive or absorptive to such
an extent that it will affect the quality of the product and thus present any
hazard.
3.53.
Pipes, hoses, pumps and valves used for treated water, starting materials and
the products shall be cleaned and sanitized according to written procedures
that detail the action limits for microbiological contamination and the
measures to be taken.
IV. Sanitation and hygiene
Principle
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The scope
of sanitation and hygiene covers personnel, premises, equipment and utensils;
in fact, anything that could become a source of contamination to the product.
All
employees shall be instructed and encouraged to report to their immediate
supervisor any conditions (plant, equipment or personnel) that they consider
may adversely affect the quality of products.
Personnel
4.1. All
personnel, prior to employment shall undergo health examinations. During the
course of their employment they shall also routinely undergo health examinations
which shall include relevant examinations appropriate to the tasks that they
are required to perform.
4.2. All
personnel shall practice good personal hygiene. They shall be trained in the
practices of personal hygiene.
4.3. Any
person shown at any time to have an apparent illness or open lesions or disease
such as active tuberculosis, acute diarrhea, cholera, dysentery, typhoid, acute
hepatitis A or E, acute respiratory tract infection or acute dermatitis or skin
infection that may adversely affect the quality of products shall not be
allowed to handle raw materials, packaging materials, in-process materials, and
finished products until the condition is improved.
4.4.
Direct contact shall be avoided between the operator's hands and raw materials,
intermediate or bulk product. Proper washing of hands and wearing of gloves
shall be used if contact with hands is unavoidable.
4.5. To
assure protection of the product from contamination as well as the safety of
the personnel, appropriate protective garments shall be worn. Soiled uniforms
shall be stored in closed containers until properly laundered.
4.6. Only
authorized personnel shall be allowed to enter production areas. Visitors or
untrained personnel shall, preferably, not be taken into the production and quality
control areas. If this is unavoidable, they shall be given information in
advance, particularly about personal hygiene and the prescribed protective
clothing. They shall be closely supervised.
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4.8. The
wearing of makeup, wrist watches and jewellery shall be prohibited in the
production area however for jewellery or objects that cannot be removed; it
must be covered by material that is maintained in an intact, clean and sanitary
condition.
Premises
4.9. Premises
used for the manufacturing of products shall be of suitable design and
construction so as to facilitate good sanitation.
4.10.
Adequate employee's washing and well ventilated toilet facilities and changing
rooms shall be provided at suitable locations.
4.11.
Suitable locker facilities shall be provided at appropriate locations for the
storage of employees’ clothing and personal property.
4.12. The
preparation, storage and consumption of food and beverages shall be restricted
to specific areas, such as meal rooms and canteen. . Facilities in such rooms
must meet sanitary standards. Meal rooms and canteen rooms shall not have
direct access to controlled areas such as production area and areas used to
store materials used for production and finished products.
4.13.
Waste material shall not be allowed to accumulate. It shall be collected in
suitable receptacles for removal to collection points outside the buildings and
disposed off safely and in a sanitary manner at regular and frequent intervals.
4.14.
Rodenticide, insecticides, fumigating agents and sanitizing materials used must
not contaminate equipment, raw materials, packaging materials, in-process
materials or finished products. There shall be a pest control programme,
documents such as layout, trending and expectations. Contract agreements shall
be established, where applicable.
4.15.
There shall be written procedures assigning responsibility for sanitation and
describing cleaning schedules, methods, equipment, materials to be used and
facilities to be cleaned in sufficient detail. Such written procedures shall be
followed.
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Equipment
and utensils
4.17.
Equipment and utensils shall be cleaned both inside and outside after use
according to established procedures. Cleaned equipment shall be kept or stored
in a clean condition and identified with the status of cleaning, and checked
for cleanliness prior to each use.
4.18.
Vacuum or wet cleaning methods are to be preferred. Compressed air and brushes
shall be used with care or avoided if possible, as they increase the risk of
product contamination.
4.19.
Cleaning agents, washing and cleaning equipment shall not be a source of
contamination. The choice of cleaning method and agents shall be carefully
considered and justified.
4.20.
Adequate space, preferably separated from processing areas, shall be provided
for cleaning and storing mobile equipment and utensils including the storage of
cleaning materials.
4.21.
Written procedures shall be established and followed for cleaning and
sanitizing of equipment, utensils and containers used in the manufacture of
health supplements. Such written procedures shall be followed.
4.22. These
procedures shall be prepared to prevent equipment contamination by cleaning or
sanitizing agents and shall at least include the following:
4.22.1.
Responsibility for cleaning;
4.22.2.
Cleaning schedule;
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4.22.4.
Equipment and materials used in cleaning operations;
4.22.5.
Methods of disassembling and reassembling equipment;
4.22.6.
Removal of previous batch identification;
4.22.7.
Protection of clean equipment and utensils from contamination prior to use.
4.23.
Records of cleaning, including the appropriate sanitizing and inspection
conducted prior to use shall be maintained.
V. Documentation
Principle
Good
documentation constitutes an essential part of the quality assurance system.
Clearly written documentation prevents errors from spoken communication and
permits tracing of batch history of the product, from receiving of starting
materials to the distribution of finished products. It shall be able to record
executed activities for maintenance, storage, quality control, distribution and
other specific matters linked to GMP.
For
manufacturing activities, a documentation system must be prepared. The system
consisting of manufacturing formulae and instructions, specifications,
procedures and records must be free from errors and clearly established.
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5.1. The
system of documentation shall be able to record the complete history of each
batch. It shall be adequate to permit investigation and tracing of any
defective products.
5.2. Documents
shall contain all necessary information, to be kept up to date and any
amendment shall be formally authorized. It shall include provision for periodic
review and revision as necessary.
5.3.
Product related records shall be retained for at least one (01) year after the
expiry date of the finished product.
5.4.
Documents shall be designed, prepared, reviewed and distributed with care. The
reproduction of working documents from master documents must not allow any
error to be introduced through the reproduction process. Reproduced documents
shall be clear, legible and duly authorized for reproduction.
5.5.
Documents shall be approved, signed and dated by appropriate and authorized
person.
5.6.
Documents shall have unambiguous contents; title, nature and purpose shall be
clearly stated. They shall be laid out in an orderly fashion and easy to be
checked.
5.7.
Documents shall be regularly reviewed and kept up to date. When a document has
been revised, systems shall be operated to prevent inadvertent use of
superseded documents.
5.8.
Documents shall not be hand-written, except in the case where documents require
the entry of data. These entries may be made in clear, legible, and indelible
handwriting. Sufficient space shall be provided for such entries.
5.9. Any
alteration made to the entry on a document shall be signed and dated. The
reason of the alteration should be recorded. The alteration shall permit the
reading of the original information.
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5.11.
Data may be recorded by electronic data processing systems, photographic or
other reliable means, but detailed procedure relating to the system in use
shall be available and the accuracy of the records shall be checked and
verified. If documentation is handled by electronic data processing methods,
only personnel who have been authorized shall be able to enter or modify data
in the computer and there shall be a record of changes and deletions. Access
shall be restricted by passwords or other means and the result of entry of
critical data shall be independently checked and verified. Batch records
electronically stored shall be protected by back-up transfer. It is
particularly important that, during the period of retention, the data are
readily available.
5.12. The
manufacturer shall practice what is documented in the written procedures. Under
circumstances where there is a change in the practice, the written procedures
shall be promptly updated. On the other hand, if a written procedure was
revised, appropriate training shall be provided to ensure that the personnel
carry out the work in accordance to the revised procedure.
Quality
control documents
5.13. The
following shall be readily available from the Quality Control Department:
5.13.1.
Specifications;
5.13.2.
Sampling procedures;
5.13.3.
Testing procedures and records (including analytical worksheets/raw data and/or
laboratory notebooks);
5.13.4.
Analytical reports and/or certificates;
5.13.5.
Data from environmental monitoring, where appropriate;
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5.14. Any
Quality Control documentation relating to a batch record shall be retained for
at least one (01) year after the expiry date of the finished product.
Specifications
5.15. The
materials used in the product shall be handled in an appropriate manner and
manufactured in an appropriate controlled condition to prevent
cross-contamination. Documented traceability of the material and suppliers is
fundamental to the quality of the finished products and shall be made
available.
Specifications
for natural materials
5.16. The
specifications for natural material shall where appropriate include the
following:
5.16.1.
Scientific name and if possible with reference to the authors;
5.16.2.
Details to the source of the natural material (country or region of origin, and
cultivation, time of harvesting, collection procedures, possible pesticides
used, etc.);
5.16.3.
Whether the whole plant/animal or only a part is used;
5.16.4.
When dried plant/animal is purchased, drying system shall be specified;
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5.16.6.
Storage conditions and precautions, when necessary;
5.16.7.
Shelf life, where applicable;
5.17.
Testing procedures shall be available if the following tests are conducted,
where appropriate:
5.17.1.
Identification tests including, where possible, tests for known active
constituents, or markers;
5.17.2.
Assay, where possible, of constituents of known therapeutic activity or
markers;
5.17.3.
Limit tests such as ash value, and presence of essential oils and loss on
drying;
5.17.4.
Tests for heavy metals and for likely contaminants, foreign materials and
adulterants;
5.17.5.
Tests for radioactivity, mycotoxin, fungal and microbial contamination;
5.17.6.
Test for residual solvents in extracts or finished products, where applicable;
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Specifications
for starting materials and packaging materials
5.18.
Specifications for starting materials and packaging materials shall include, if
applicable. (if the starting material is a natural material, refer to section
5.17).
5.18.1. A
description of the materials, including:
5.18.1.1.
The designated name and the internal code reference;
5.18.1.2.
The reference, if any, to a pharmacopoeia monograph;
5.18.1.3.
The approved suppliers and, if possible, the original producer of the products;
5.18.1.4.
A specimen of printed materials.
5.18.2.
Directions for sampling and testing or reference to procedures.
5.18.3.
Qualitative and quantitative requirements with acceptance limits.
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5.18.5.
The maximum period of storage before re-examination.
Specifications
for intermediate and bulk product
5.19.
Specifications for intermediate and bulk products shall be available if these
are purchased or transferred, or if data obtained from intermediate products
are used for the evaluation of the finished product. The specifications shall
be similar to specifications for starting materials or for finished products,
as appropriate.
Specifications
for finished products
5.20. The
specifications for finished product where appropriate shall include the
following tests:
5.20.1.
Microbial limits;
5.20.2.
Heavy metals limits;
5.20.3.
Uniformity of weight (for tablets and capsules), disintegration (for tablets,
capsules and pills), hardness and friability (for tablets), and viscosity (for
internal and external liquids);
5.20.4.
Physical appearance such as color, taste, texture, size, etc.
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5.21.
Other contents:
5.21.1.
The designated name of the product and the internal code reference where
applicable;
5.21.2.
The formula or a reference to;
5.21.3. A
description of the dosage form and package details;
5.21.4.
Directions for sampling and testing or a reference to procedures, where
applicable;
5.21.5.
The qualitative and quantitative requirements, with the acceptance limits,
where applicable;
5.21.6.
The storage condition and any special handling precautions, where applicable;
5.21.7.
The shelf life.
Production
documents (refer to section 11.5)
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Formally
authorized Manufacturing Formula and Processing Instructions shall exist for
each product and batch size to be manufactured. They are often combined in one
document.
5.22. The
Manufacturing Formula shall include:
5.22.1.
The name of the product, with a product reference code relating to its
specification;
5.22.2. A
description of the product dosage form, strength of the product and batch size;
5.22.3. A
list of all starting materials to be used, with the amount of each, described
using the designated name and a reference which is unique to that material.
Mention shall be made of any substance that may disappear in the course of
processing;
5.22.4. A
statement of the expected final yield with the acceptable limits, and of
relevant intermediate yields, where applicable.
5.23. The
Processing Instructions shall include:
5.23.1. A
statement of the processing location and the principal equipment to be used;
5.23.2.
The methods, or reference to the methods, to be used for setting up the
equipment (e.g. Cleaning, assembling, calibrating);
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5.23.4.
The instructions for any in-process controls with their limits;
5.23.5.
Where necessary, the requirements for bulk storage of the products; including
the container, labeling and special storage conditions where applicable;
5.23.6.
Any special precautions to be observed.
5.24. The
processing instructions shall describe the different operations carried out
upon the crude material such as sorting, cleaning, drying, crushing and
sifting, and include drying time and temperatures, and methods used to control
fragment or particle size. It shall also describe the sieving process or other
methods of removing foreign materials.
5.25. In
particular, there shall be written instructions and records, which ensure that
each container of the product is carefully examined to detect any
adulteration/substitution or presence of foreign matter, such as metal or glass
pieces, animal parts or excrement, stones, sand, etc., or rot and signs of decay.
5.26. For
product preparation, instructions shall include details of base or solvent,
time and temperatures of extraction, details of any concentration stages and
methods used.
Packaging
Instructions
5.27. There
shall be formally authorized Packaging Instructions for each product, pack size
and type. These shall normally include, or have a reference to the following:
5.27.1.
Name of the product;
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5.27.3.
The pack size expressed in terms of the number, weight or volume of the product
in the final container;
5.27.4. A
complete list of all the packaging materials required for a standard batch
size, including quantities, sizes and types, with the code or reference number
relating to the specifications of each packaging material;
5.27.5.
Where appropriate, an example or reproduction of the relevant printed packaging
materials, and specimens indicating where to apply batch number references, and
shelf life of the product;
5.27.6.
Special precautions to be observed, including a careful examination of the area
and equipment in order to ascertain the line clearance before operations begin;
5.27.7. A
description of the packaging operation, including any significant additional
operations, and equipment to be used;
5.27.8.
Details of in-process controls with instructions for sampling and acceptance
limits.
Batch
processing records
5.28.
Batch Processing Record is that part of Batch Manufacturing Record and shall be
kept for each batch processed. It shall be based on the relevant parts of the
currently approved Manufacturing Formula and Processing Instructions. The
method of preparation of such records shall be designed to avoid transcription
errors. The record shall carry the batch number of the product being
manufactured.
5.29.
Before any processing begins, there shall be recorded verification that the
equipment and work station are clear of previous products, documents or
materials not required for the planned process, and that equipment is clean and
suitable for use.
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5.30.1.
Name of the product;
5.30.2.
Dates and times of initiation, of significant intermediate stages and of
completion of production;
5.30.3.
Name of the person responsible for each stage of production;
5.30.4.
Date and the signature of the operator of different significant steps of
production and, where appropriate, of the person who checked each of these
operations (e.g. weighing);
5.30.5.
The batch number and/or analytical control number as well as the quantities of
each starting material actually weighed (including the batch number and amount
of any recovered or reprocessed materials added);
5.30.6.
Any relevant processing operation or event and major equipment used;
5.30.7. A
record of the in-process controls and the date and signature of the person(s)
carrying them out, and the results obtained;
5.30.8.
The product yield obtained at different and pertinent stages of manufacture;
5.30.9.
Notes on special problems including details, with signed authorization for any
deviation from the manufacturing formula and processing instructions.
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5.31. A
Batch Packaging Record is part of Manufacturing Record and shall be kept for
each batch or part of batch processed. It shall be based on the relevant parts
of the Packaging Instructions and the method of preparation of such records
shall be designed to avoid transcription errors. The record shall carry the
batch number and the quantity of bulk product to be packed, as well as the
batch number and the planned quantity of finished product that will be
obtained.
5.32.
Before any packaging operation begins, there shall be recorded checks that the
equipment and work station are clear of previous products, documents, or
materials not required for the planned packaging operations, and that equipment
is clean and suitable for use.
5.33. The
following information shall be entered at the time each action is taken and,
after completion, the record shall be dated and signed in agreement by the
person(s) responsible for the packaging operations:
5.33.1.
The name of the product;
5.33.2.
The date(s) and times of the packaging operations. When there is the risk of
contamination, the packaging activity shall be done within the day itself;
5.33.3.
The name of the responsible persons carrying out the packaging operation;
5.33.4.
The date and signature of the operators of the different significant steps;
5.33.5.
Records of verification for identity and conformity with the packaging
instructions including the results of in-process controls;
5.33.6.
Details of the packaging operations carried out, including references to
equipment and the packaging lines used;
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5.33.8.
Notes on any special problems or unusual events including details, with date
and signed authorization from the manufacturing formula and processing
instructions;
5.33.9.
The quantities and reference number or identification of all printed packaging
materials and bulk product issued/used/destroyed/returned to stock and the
quantities of obtained product, in order to provide for an adequate
reconciliation.
Standard
Operating Procedures (SOPs) and records
5.34.
There shall be written procedures and records for the receipt of each delivery
of each starting materials and packaging material.
The
records of the receipts shall include:
5.34.1.
The name of material on the delivery note and the containers;
5.34.2.
The “in-house” name and /or code of material (if different from the name of the
material on the delivery note and the containers);
5.34.3.
Date of receipt, date and signature of the receiving staff;
5.34.4. Supplier’s
name and manufacturer’s name;
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5.34.6.
Total quantity and number of containers received;
5.34.7.
The batch number assigned after receipt;
5.34.8.
Any relevant comment (e.g. State of the containers).
5.35.
There shall be written procedures for the internal labeling, quarantine and
storage of starting materials, packaging materials and other materials, as
appropriate.
5.36.
Standard operating procedures shall be available for the operation of each equipment
and placed in close proximity to the instrument or equipment.
5.37.
There shall be standard operating procedures for sampling, which specify the
person(s) authorized to take samples, and the sampling instructions.
5.38.
There shall be a standard operating procedure describing the details of the
batch/lot numbering system, with the objective of ensuring that each batch of
intermediate, bulk, or finished product is identified with a specific batch
number. The batch numbering procedures shall assure that the same batch numbers
will not be repeatedly used; this applies also to reprocessing.
5.39.
Batch number allocation shall be immediately recorded, e.g. in a logbook. The
record shall include date of allocation, product identity, and size of batch.
5.40. The
standard operating procedures for batch numbering that are applied to the
processing stage and to the respective packaging stage shall be related to each
other.
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5.42.
Records shall be maintained of the distribution of each batch of a product in
order to facilitate the recall of the batch if necessary.
5.43.
Standard operating procedures and associated records of actions taken or, where
appropriate, conclusions reached shall be available for:
5.43.1.
Equipment assembly;
5.43.2.
Operation of analytical apparatus and calibration;
5.43.3.
Maintenance, cleaning, and sanitization of equipment and premises;
5.43.4.
Personnel matters including qualification, GMP training, clothing, and hygiene;
5.43.5.
Environmental monitoring;
5.43.6.
Pest control;
5.43.7.
Adverse product reactions, complaints and product recalls;
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5.43.9.
Disposal and destruction of the rejected products/materials;
5.43.10.
Self-inspection/quality audit.
5.44.
Logbooks shall be kept for major or critical equipment and shall record, as
appropriate, any calibrations, maintenance, cleaning, or repair operations,
including dates and the identity of the people who carried these operations
out.
5.45.
Logbooks shall be recorded in chronological order for the use of all equipment
and the areas where the products have been processed.
5.46.
Several of the above- mentioned procedures, specifications and/or records may
be combined together in one specific document.
VI. Production
Principle
With the
premises and equipment provided, the processes used in production shall be
capable of yielding finished products which conform to their specifications.
Defined manufacturing procedures are necessary to ensure that production,
quality control and other relevant personnel are instructed on the details of
the processes concerned.
General
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6.2. All
handling of materials and products, such as receipt and quarantine, sampling,
storage, labeling, dispensing, processing, packaging and distribution shall be
done in accordance with written procedures or instructions and, where
necessary, recorded.
6.3. All
incoming materials shall be checked to ensure that the consignment corresponds
to the order. Containers shall be cleaned where necessary and labeled with the
prescribed data.
6.4.
Damage to containers and any other problem, which might adversely affect the
quality of a material, shall be investigated, recorded and reported to the
Quality Control Department.
6.5.
Incoming materials and finished products shall be physically or
administratively quarantined immediately after receipt or processing, until
they have been released for use or distribution.
6.6.
Intermediate and bulk products purchased as such shall be handled on receipt as
though they were starting materials.
6.7. All
materials and products shall be stored under the appropriate conditions
established by the manufacturer and in an orderly fashion to permit batch
segregation and stock rotation.
6.8.
Checks on yields, and reconciliation of quantities, shall be carried out as
necessary to ensure that there are no discrepancies outside acceptable limits.
6.9.
Operations on different products shall not be carried out simultaneously or
consecutively in the same room unless there is no risk of mix-up or cross -
contamination.
6.10. At
every stage of processing, products and materials shall be protected from
microbial and other contamination. Any treatment used to reduce
fungal/microbial contamination or other infestation shall be documented.
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6.12. At
all times during processing, all materials, bulk containers, major items of
equipment and where appropriate, rooms used shall be labeled or otherwise
identified with an indication of the product or material being processed, its
strength (where applicable) and batch number. Where applicable, this indication
shall also mention the stage of production.
6.13.
Labels applied to containers, equipment or premises shall be clear, unambiguous
and in the company’s agreed format. It is often helpful in addition to the
wording on the labels to use colors to indicate status (for example,
quarantined, accepted, rejected, clean, etc.).
6.14.
Checks shall be carried out to ensure that pipelines and other pieces of
equipment used for the transportation of products from one area to another are
connected in a correct manner.
6.15. Access
to production premises shall be restricted to authorized personnel.
6.16.
Water used as ingredients or for final rinsing of production equipment shall be
treated to minimize microbial contamination
Verification
6.17.
Verification work that is needed to prove control of critical aspects of
particular operations shall be identified and documented. Significant changes
to the facilities, equipment and the processes which may affect the quality of
the product shall be verified. A risk assessment approach shall be used to
determine the scope and extent of verification.
(Refer to
section 11.2).
Prevention
of cross-contamination in production
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6.19.
Cross-contamination shall be avoided by appropriate technical or organizational
measures, for example:
6.19.1.
Production in segregated area, or by campaign (separation in time) followed by
appropriate cleaning.
6.19.2.
Providing appropriate air-locks and air extraction.
6.19.3.
Minimizing the risk of contamination caused by recirculation or re-entry of
untreated or insufficiently treated air.
6.19.4.
Keeping protective clothing inside areas where products with special risk of
cross-contamination are processed.
6.19.5.
Using the approved cleaning and decontamination procedures of known
effectiveness, as ineffective cleaning of equipment is a common source of
cross-contamination.
6.19.6.
Using “closed systems” of production.
6.19.7.
Testing for residues and use of cleaning status labels on equipment.
6.19.8.
Specific provisions for sampling, weighing, mixing and processing operations of
crude plants whenever dust is generated.
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Starting
materials
6.21. The
purchase of starting materials is an important operation which shall involve
personnel who have a particular and thorough knowledge of the suppliers.
6.22.
Starting materials shall only be purchased from approved suppliers and, where
possible, directly from the producer. It is recommended that the specifications
established by the manufacturer for the starting materials are discussed with
the suppliers. It is of benefit that all aspects of the production and control
of the starting material in question, including handling, labeling and
packaging requirements, as well as complaints and rejection procedures are
contractually agreed between the manufacturer and the supplier. The supplier of
the materials shall be adequately assessed and the assessment shall be
recorded.
The
supplier assessment programme shall include the establishment of an approved
supplier list which may include alternative supplier, initial assessment before
placing the supplier on the approved supplier list and periodic assessment
thereafter, provision for on-site audit of the supplier premises, etc.
6.23. For
each delivery, the containers shall be checked for integrity of package and
seal and for correspondence between the delivery note and the supplier's
labels.
6.24. If
one material delivery is made up of different batches, each batch shall be
considered as separate for sampling, testing and release.
6.25.
Starting materials in the storage areas shall be appropriately labeled. Labels
shall bear at least the following information:
6.25.1.
The designated name of the product and the internal code reference where
applicable;
6.25.2. A
batch number given at receipt;
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6.26.
There shall be appropriate procedures or measures to assure the identity of the
contents of each container of starting material. Bulk containers from which
samples have been drawn shall be identified.
6.27.
Only starting materials which have been released by the Quality Control
Department and which are within their shelf life shall be used.
6.28.
Starting materials shall only be dispensed by designated persons, following a
written procedure, to ensure that the correct materials are accurately weighed
or measured into clean and properly labeled containers.
6.29.
Each dispensed material and its weight or volume shall be independently checked
and the check recorded.
6.30.
Materials dispensed for each batch shall be kept together and conspicuously
labeled as such.
Processing
operations: Intermediate and bulk products
6.31.
Before the introduction of a Master Formula it shall be evaluated sufficiently
to determine that it is suitable for routine processing operations, and the
ability of the process to be reproducible.
6.32.
Production personnel shall follow defined and authorized procedures for every
stage of each manufacturing process.
6.33. Any
deviation from defined procedures shall be recorded and agreed upon between the
head of Production Department and the head of Quality Control Department.
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6.35. Any
necessary in-process controls and environmental controls shall be carried out
and recorded.
6.36.
Before applying labels or marks to materials and equipment, all irrelevant
labels or marks previously used shall be removed.
6.37. The
final yield of each production stage shall be recorded and checked against the
theoretical yield. In the event of a significant variation, steps shall be
taken to prevent release or further processing of the batch, until an
appropriate investigation is made.
6.38.
Storage of materials and bulk products must be under controlled condition.
Packaging
materials
6.39. The
purchase, handling and control of primary and printed packaging material shall
be accorded attention similar to that given to starting materials.
6.40.
Particular attention shall be paid to printed materials. They shall be stored
in adequately secure condition such as to exclude unauthorized access. Cut
labels and other loose printed materials shall be stored and transported in
separate closed containers so as to avoid mix-ups. Packaging materials shall be
issued for use only by authorized personnel following an approved and
documented procedure.
6.41.
Each delivery or batch of printed or primary packaging material shall be given
a specific reference number or identification mark.
6.42.
Outdated or obsolete primary packaging material or printed packaging material
shall be destroyed and this disposal recorded.
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6.43.
When setting up a programme for the packaging operations, particular attention shall
be given to minimizing the risk of the cross-contamination, mix-ups or
substitutions. Different products shall not be packaged in close proximity
unless there is physical segregation.
6.44.
Before packaging operations, steps shall be taken to ensure that the work area,
packaging lines, printing machines and other equipment are clean and free from
any products, materials or documents previously used, if these are not required
for the current operation. The line-clearance shall be performed according to
an appropriate checklist.
6.45. The
name and batch number of the product being handled shall be displayed at each
packaging station or line.
6.46. All
products and packaging materials to be used shall be checked on delivery to the
packaging department for quantity, identity and conformity with the Packaging
Instructions.
6.47.
Primary packaging shall be clean prior to use. Measures shall be taken to
prevent any contaminants such as glass fragments and metal particles.
6.48.
Normally, filling and sealing shall be followed as quickly as possible by
labeling. If it is not the case, appropriate procedure shall be applied to
ensure that no mix-ups or mislabeling could occur.
6.49. The
correct performance of any printing operation (for example batch/lot numbers,
expiry dates) to be done separately or in the course of the packaging shall be
checked and recorded. Attention shall be paid to printing by hand which shall
be re-checked at regular intervals.
6.50.
Special care shall be taken when using cut-labels and when over-printing is
carried out off-line. Roll-feed labels are normally preferable to cut-labels,
in helping to avoid mix-ups.
6.51.
Checks shall be made to ensure that any electronic code readers, label counters
or similar devices are operating correctly.
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6.53.
On-line control of the product during packaging shall include at least checking
the following:
6.53.1.
General appearance of the packages;
6.53.2.
Whether the packages are complete;
6.53.3.
Whether the correct products and packaging materials are used;
6.53.4.
Whether any over-printing is correct;
6.53.5.
Correct functioning of line monitors.
6.54. Samples
taken away from the packaging line shall not be returned.
6.55.
Products which have been involved in an unusual event shall only be
reintroduced into the process after special inspection, investigation and
approval by authorized personnel. Detailed record shall be kept of this
operation.
6.56. Any
significant or unusual discrepancy observed during reconciliation of the amount
of bulk product and printed packaging materials and the number of units
produced shall be investigated and satisfactorily accounted for before release.
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Finished
products
6.58.
Finished products shall be held in quarantine until their final release under
conditions established by the manufacturer.
6.59. The
evaluation of finished products and documentation which is necessary before
release of product for sale is described in Section VII. Quality Control.
6.60.
After release, finished products shall be stored as usable stock under
conditions established by the manufacturer.
Rejected,
recovered and returned materials
6.61.
Rejected materials and products shall be clearly marked as such and stored
separately in restricted areas. They shall either be returned to the suppliers
or, where appropriate, reprocessed or destroyed. Whatever action is taken shall
be approved and recorded by authorized personnel.
6.62. The
reprocessing of rejected products shall be exceptional. It is only permitted if
the quality of the final product is not affected, if the specifications are met
and if it is done in accordance with a defined and authorized procedure after
evaluation of the risks involved. Record shall be kept of the reprocessing.
6.63. The
recovery of all or part of earlier batches which conform to the required
quality by incorporation into a batch of the same product at the defined stage
of manufacture shall be authorized beforehand. This recovery shall be carried
out in accordance with a defined procedure after evaluation of the risks
involved, including any possible effect on shelf life. The recovery shall be
recorded.
6.64. The
need for additional testing of any finished product which has been reprocessed,
or into which a recovered product has been incorporated, shall be considered by
the Quality Control Department.
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VII. Quality control
Principle
Every
manufacturing establishment shall have a quality control system so designed as
to ensure that the products are manufactured in accordance with adequate
conditions and procedures and continue to meet the established specifications.
Quality
control is not confined to laboratory operations, but must involve all
decisions which may concern the quality of the product.
For this
purpose there shall be an appropriate and independent Quality Control
Department.
General
7.1.
Quality control is concerned with sampling, specifications, testing, organization,
documentation and release procedures which ensure that the necessary tests are
in fact carried out, and that the materials are not released for use, nor
products released for sale and supply until their quality has been assessed to
be satisfactory.
7.2. The
Quality Control Department shall have a designated area with sufficient and
well trained staff to perform any required analysis before, during and after
manufacture.
7.3. If
the in-house Quality Control Department cannot perform certain specific
analysis, the services of accredited/recognized external laboratory can be used
to conduct the tests.
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7.5.
Quality Control personnel shall have access to production areas for sampling
and investigation as appropriate.
7.6.
Quality Control personnel shall have particular expertise in products in order
to be able to carry out identification tests and recognize adulteration, the
presence of fungal growth, infestations, and non-uniformity when receiving and
checking crude materials.
7.7. The
identity and quality of materials and finished products shall be
checked/tested. The presence of individual ingredient in pre-mixes shall be
confirmed.
7.8.
Besides these principal duties, the Quality Control Department as a whole will
also have other duties, such as to establish and implement all quality control
procedures, keep the reference samples of materials and products, ensure the
correct labeling of containers of materials and products, ensure the monitoring
of the stability of the products, etc. All these operations shall be carried
out in accordance with written procedures and recorded.
7.9. The
stability of the finished product shall be monitored according to a continuous
appropriate programme that will permit the detection of any stability issue
associated with the formulation in the marketed package.
Sampling
7.10. Due
to the fact that crude material shall be an aggregate of individual natural
materials i.e. contain an element of heterogeneity, the sampling has to be carried
out with special care by competent personnel. Each batch shall be identified by
its own documentation.
7.11. The
sample taking shall be done in accordance with approved written procedures that
describe:
7.11.1.
The method of sampling;
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7.11.3.
The amount of the sample to be taken;
7.11.4.
Instructions for any required subdivision of the sample;
7.11.5.
The type and condition of the sample container to be used;
7.11.6.
The identification of containers sampled;
7.11.7.
The storage conditions;
7.11.7.
Instructions for the cleaning and the storage of sampling equipment.
7.12.
Reference samples shall be representative of the batch of materials or products
from which they are taken. Other samples may also be taken to monitor the most
stressed part of a process. (e.g. beginning or end of a process).
7.13.
Sample containers shall bear a label indicating the contents, with the batch
number, the date of sampling and the containers from which samples have been
drawn.
7.14.
Reference samples from each batch of finished products shall be retained till
one year after the expiry date. Finished products shall usually be kept in
their final packaging and stored under the recommended conditions. Samples of
starting materials (other than solvents, gases and water) shall be retained for
at least two (02) years after the release of the product if their stability
allows. This period may be shortened if their stability, as mentioned in the
relevant specification, is shorter. Reference samples of materials and products
shall be of a size sufficient to permit at least a full re-examination.
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7.15. All
testing operations described in the marketing authorization shall be carried
out according to approved methods which shall be internationally accepted
(refer to section 11.1).
7.16. The
results obtained shall be recorded and verified to make sure that they are
consistent with each other. Any calculations shall be critically examined.7.17.
The test performed shall be recorded and the records shall include at least the
following data:
7.17.1.
Name of the material or product and, where applicable, dosage form;
7.17.2.
Batch number and, where appropriate, the manufacturers and/or supplier;
7.17.3.
References to the relevant specifications and testing procedures;
7.17.4.
Test results, including observations and calculations, and reference to any
certificates of analysis;
7.17.5.
Dates of testing, the name of the analyst and the name of the external
laboratory, if applicable;
7.17.6.
Date and signature of the persons who performed the testing;
7.17.6.
Date and signature of the persons who verified the testing and the
calculations, where appropriate;
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7.18. All
the in-process controls, including those made in the production area by
production personnel, shall be performed according to methods approved by
Quality Control and the results recorded.
7.19.
Special attention shall be given to the quality of laboratory reagents,
volumetric glassware and solutions, reference standards and culture media. They
shall be prepared in accordance with written procedures and recorded.
7.20.
Laboratory reagents intended for prolonged use shall be marked with the
preparation date and the signature of the person who prepared them. The expiry
date of unstable reagents and culture media shall be indicated on the label,
together with specific storage conditions. In addition, for volumetric
solutions, the last date of standardization and the last current factor (F)
shall be indicated.
7.21. For
some kinds of data (e.g. analytical test results, yields, environmental
controls) it is recommended that records in a manner permitting trend evaluation
be kept.
7.22. In
addition to the information which is part of the batch record, other original
data such as laboratory notebooks and/or reports shall be retained and readily
available.
Ongoing
stability programme
7.23.
After marketing, the stability of the product shall be monitored according to a
continuous appropriate programme that will permit the detection of any
stability issue associated with the formulation in the marketed package.
7.24. The
purpose of the on-going stability programme is to monitor the product over its
shelf life and to determine that the product remains, and can be expected to
remain, within specifications under the labeled storage conditions.
7.25.
This mainly applies to the product in the package in which it is marketed/sold,
but consideration shall also be given to the inclusion in the programme of bulk
product. For example, when the bulk product is stored for a long period before
being packaged and/or shipped from a manufacturing site to a packaging site,
the impact on the stability of the packaged product shall be evaluated and
studied under ambient conditions. In addition, consideration shall be given to
intermediates that are stored and used over prolonged periods. Stability
studies on reconstituted product are performed during product development and
need not be monitored on an on-going basis. However, when relevant, the
stability of reconstituted product can also be monitored.
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7.27. The
protocol for an on-going stability programme shall extend to the end of the
shelf life period and shall include, but not be limited to, the following
parameters:
7.27.1.
Number of batch(es) per strength and different batch sizes, where applicable;
7.27.2.
Relevant physical, chemical, microbiological and biological test methods,
stability indicating parameters, where applicable.
7.27.3.
Acceptance criteria;
7.27.4.
Reference to test methods;
7.27.5.
Description of the container closure system(s);
7.27.6.
Testing intervals (time points);
7.27.7.
Description of the conditions of storage;
7.27.8.
Other applicable parameters specific to the finished product.
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7.29. The
number of batches and frequency of testing shall provide a sufficient amount of
data to allow for trend analysis. Unless otherwise justified, at least 1 batch
per year of product manufactured in every strength and every primary packaging
type, if relevant, shall be included in the stability programme (unless none
are produced during that year). Scientific justification has to be provided in
the event that the principle of bracketing and matrixing designs is applied.
7.30. In
certain situations, additional batches shall be included in the on-going
stability program. For example, an on-going stability study shall be conducted
after any significant change or significant deviation to the process or package.
Any reworking, reprocessing or recovery operation shall also be considered for
inclusion.
7.31.
Results of on-going stability studies shall be made available to key personnel
and, in particular, to the authorized person(s). Where on-going stability
studies are carried out at a site other than the site of manufacture of the
bulk or finished product, there shall be a written agreement between the
parties concerned. Results of on-going stability studies shall be available at
the site of manufacture for review by the competent authority.
7.32. Out
of specification or significant atypical trends shall be investigated. Any
confirmed out of specification result, or significant negative trend, shall be
reported to the relevant competent authorities. The possible impact on batches
on the market shall be considered in accordance section IX. Complaints and
Product Recalls of the GMP Guide and in consultation with the relevant
competent authorities.
7.33. A summary
of all the data generated, including any interim conclusions on the programme,
shall be written and maintained. This summary shall be subjected to periodic
review.
7.34. For
stability study requirements, reference shall be made to section 11.3.
VIII. Contract manufacture and analysis
Principle
Contract
manufacture and analysis must be correctly defined, agreed and controlled in
order to avoid misunderstandings which could result in a product or work of
unsatisfactory quality. There must be a written contract between the Contract
Giver and the Contract Acceptor which clearly establishes the duties and
responsibilities of each party. The contract must clearly state the way in
which the authorized person releasing each batch of product for sale exercises
his full responsibility.
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8.1.
Contract manufacture shall have a written contract agreement between the
Contract Giver and the Contract Acceptor, which clearly establishes the duties and
responsibilities of each party. All arrangements for contract manufacture,
including any proposed changes in technical or other arrangements, shall be in
accordance with the NRA requirements for the product concerned.
Contract
analysis
8.2.
Contract analysis must have a written contract agreement between the Contract
Giver and the Contract Acceptor which clearly establishes the duties and
responsibilities of each party.
All
arrangements for contract analysis, including any proposed changes in technical
or other arrangements, shall be in accordance with the NRA requirements for the
product concerned.
The
Contract Giver
8.4. The
Contract Giver shall be responsible for assessing the competency of the
Contract Acceptor in successfully carrying out the work/test required and for
ensuring by means of the contract that the principles of GMP described in these
guidelines are followed.
8.5. The
Contract Giver shall provide the Contract Acceptor with all the information
necessary to carry out the contracted operations correctly in accordance with
the NRA requirements. The Contract Giver shall ensure that the Contract
Acceptor is fully aware of any problems associated with the product or the work
which might pose a hazard to his premises, equipment, personnel, other
materials or other products.
8.6. The
Contract Giver shall ensure that all products and materials delivered by the
Contract Acceptor comply with their specifications.
The
Contract Acceptor
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8.8. The Contract
Acceptor shall ensure that all products or materials received are suitable for
their intended purpose.
8.9. The
Contract Acceptor shall not pass to a third party any of the work entrusted to
him under the contract without the Contract Giver’s prior to evaluation and
approval of the arrangements. Arrangements made between the Contract Acceptor
and any third party shall ensure that the manufacturing and the analytical
information is made available in the same way as between the original Contract
Giver and Contract Acceptor.
8.10. The
Contract Acceptor shall refrain from any activity that may adversely affect the
quality of the product manufactured/tested for the Contract Giver.
The
Contract
8.11. A
contract shall be drawn up between the Contract Giver and the Contract
Acceptor, which specifies their respective responsibilities relating to the
manufacture and the control of the product. Technical aspects of the contract
shall be drawn up by competent persons suitably knowledgeable in traditional
medicines and health supplements manufacturing, analysis and GMP. All
arrangement for manufacture and analysis must be in accordance with the NRA
requirement and agreed by both parties.
8.12. The
contract shall specify the way in which the head of Quality Control Department
releasing the batch for sale ensures that each batch has been manufactured and
checked for compliance with the requirements of the NRAs.
8.13. The
contract shall describe clearly who is responsible for purchasing materials,
testing and releasing materials, undertaking production and quality controls,
including in-process controls, and who has responsibility for sampling and
analysis. In case of contract analysis, the contract shall state whether or not
the Contract Acceptor shall take samples at the premises of the manufacturer.
8.14.
Manufacturing, analytical and distribution records, and reference samples shall
be kept by, or be available to, the Contract Giver. Any records relevant to
assessing the quality of a product in the event of complaints or a suspected
defect must be accessible and specified in the defect/recall procedures of the
Contract Giver.
8.15. The
contract shall permit the Contract Giver to visit the facilities of the
Contract Acceptor.
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IX. Complaints and product recalls
Principle
All
complaints and other information concerning potentially defective products must
be kept and reviewed according to written procedures. In order to provide for
all contingencies, a system shall be designed to recall, if necessary, promptly
and effectively products known or suspected to be defective from the market.
Product
complaints
9.1.
Product complaints are usually concerned with the quality of the product such
as its physical properties, or condition of its packaging. Complaints (internal
or external) could be made to the manufacturer, verbally or in writing by
consumers, distributors or the NRA.
9.2. All
complaints shall be investigated and evaluated. Written procedures describing
the handling of all written and verbal complaints regarding the product shall
be established and followed. Such procedures shall include provisions for
review by the Quality Control unit. A written record of each complaint shall be
maintained in a file designated for product complaints.
9.3. A
person shall be designated responsible for handling the complaints.
9.4.
There shall be written procedures describing the action to be taken, including
the need to consider a recall, in the case of a complaint concerning a possible
product defect.
9.5. Any
complaint concerning a product defect shall be recorded with all the original details
and thoroughly investigated. The person responsible for Quality Control shall
be part of the team.
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9.7. If a
product defect is discovered or suspected in a batch, consideration shall be
given to check other batches in order to determine whether they are also
affected. In particular, other batches which may contain reworks of the
defective batch shall be investigated.
9.8. All
decisions and measures taken as a result of a complaint shall be recorded and
referenced to the corresponding batch records.
9.9.
Complaint records shall be reviewed regularly for any indication of specific or
recurring problems requiring attention and possibly the recall of marketed
products.
9.10. For
recurring problem, a trending shall be established in order to identify the
possible systemic defects.
9.11. The
NRA shall be informed if a manufacturer is considering action following
possibly faulty manufacture, product deterioration, or any other serious
quality problems with a product.
9.12. The
NRA and the complainant shall be furnished with a summary of the action taken.
Product
recalls
9.13.
Responsibility and procedures for recall of the product shall be established by
the manufacturer to facilitate the recall of a batch from any link of the
distribution chain when this becomes necessary.
9.14. The
recall procedures shall take into account the degree and level of recall which
in line with the NRA requirement.
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9.16. A
person shall be designated as responsible for execution and coordination of
recalls and shall be supported by sufficient staff to handle all the aspects of
the recalls with the appropriate degree of urgency. This responsible person
shall normally be independent of the sales and NRA requirements.
9.17.
There shall be established written procedures, regularly checked and updated
when necessary, in order to organize any recall activity.
9.18.
Recall operation shall be capable of being initiated immediately and at any
time.
9.19. All
NRA of all countries to which products may have been distributed shall be
informed immediately if products are intended to be recalled because they are,
or are suspected of being defective.
9.20. The
distribution records shall be readily available to the person(s) responsible
for recalls, and shall contain sufficient information on
distributor/retailer/wholesalers and directly supplied customers (with latest
and valid addresses, contact number including mobile phone, phone and/or fax
numbers inside and outside working hours, batches and amounts delivered),
including those for exported products.
9.21.
Recalled products shall be identified, recorded and stored separately in a
secure area while awaiting a decision on their fate.
9.22. The
progress of the recall process shall be recorded and a final report issued,
including reconciliation between the delivered and recovered quantities of the
products.
9.23. The
effectiveness of the arrangements for recalls shall be evaluated regularly.
Complaints
on adverse product reactions
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X. Self-inspection
Principle
Self-inspections
shall be conducted in order to monitor the implementation and compliance with
Good Manufacturing Practice principles and to propose necessary corrective
measures.
10.1.
Personnel matters, premises, equipment, documentation, production, quality
control, distribution of the products, arrangements for dealing with complaints
and recalls, and self -inspection, shall be examined at intervals following a
pre-arranged programme in order to verify their conformity with the principles
of Quality Assurance.
10.2.
Self-inspection shall be conducted in an independent and detailed way by
designated competent person(s) from the company. The independent audits by
external experts may also be useful.
10.3. All
self-inspections shall be recorded. Reports shall contain all the observations
made during the inspections and, where applicable, proposals for corrective
actions and preventive actions, and corresponding time frames. Statements on
the actions subsequently taken shall also be recorded.
10.4.
Reference shall be made to section 11.4. Self-inspection questionnaire.
XI. Other contents
11.1. List
of internationally accepted references for test methods
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2)
International Organization for Standardization (ISO):
- ISO
Standard - ICS 67 - Food Technology;
- ISO
Standard - ICS 67.050 - – General methods of tests and analysis for food
products.
3)
American Herbal Pharmacopoeia (AHP).
4) Food Chemicals Codex (FCC).
5)
Association of Official Analytical Chemist International: Official Methods of
Analysis.
6)
Microbiologicals: US Food and Drug Administration Bacteriological Analytical
Manual.
7) Office
of Dietary Supplement, National Institute of Health. US: Dietary Supplement
Analytical Methods/ Reference Materials (AMRM) Program.
http://ods.od.nih.gov/Research/AMRMProgramWebsite.aspx.
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9) TLC
Atlas of Chinese Crude Drugs in Pharmacopeia of the People's Republic of China
Vol. 1.
Note: The use of this list is subject to the consideration,
regulations and prerogative of each national regulatory authority. Other
references may be considered by national regulatory authority, provided that
the test methods are validated against guidelines/parameters defined by
ICH/ASEAN Guidelines for Validation of Analytical Procedures.
11.2.
Verification
Principle
11.2.1.
This Appendix describes the principles of verification which are applicable to
the manufacture of health supplements.
Accordingly,
and in this Appendix, verification shall refer to the documented act or conduct
of confirmation that the control or procedure required in a particular critical
aspect of manufacturing operation has been complied with or satisfactorily
implemented by the manufacturer based on risk assessment and risk management.
Re-verification
shall be performed if there are significant changes to the facilities, systems,
processes and equipment that may have impact on the quality of the finished
products, and the changes would require regulatory approval. Where there are no
significant changes, periodic review shall be performed to show that the
facilities, systems, processes and equipment continue to meet the prescribed
requirements.
Documentation
11.2.2. A
verification programme which includes written procedure(s) shall be established
to specify how the verification activities will be carried out. The
documentation provided will demonstrate the quality assurance systems needed to
produce quality health supplements. This includes the QA systems, which consist
of elements that address matters such as roles and responsibilities, employee
training, document management, equipment calibration and maintenance,
manufacturing and laboratory control procedures, and product shelf life
evaluation.
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Verification
of machinery and equipment
11.2.3.
Equipment and machinery shall be periodically verified to determine if they are
still operating in a valid state.
During verification,
it is important to use calibrated reference material e.g. NIST traceable
calibrated thermometer to verify the temperature of process to determine its
valid state.
Machinery
and equipment to be used shall have been verified prior to the verification of
process and staff taking part in verification work shall have been
appropriately trained.
Verification
of process
11.2.4.
General
Verification
of process contributes to assuring product quality and the basic principle of quality
assurance is that a product shall be produced under such condition that is fit
for its intended use.
The basic
principle of quality assurance is that a product shall be consistently produced
and controlled to the quality standards appropriate to their intended use and
as required by the marketing authorization and product specification.
11.2.5.
Verification of process may involve demonstration, testing & analysis and
in-process control, or other relevant to confirm that critical processes are
kept under control. A process verification report shall be prepared to provide
evidence that the process has been verified.
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Demonstration
is the operation of an item to provide evidence that it can meet its
predetermined specifications and quality attributes.
Demonstrations
can be conducted in actual or simulated environments.
b)
Testing and Analysis
Test is
the application of scientific principles and procedures to determine the
properties or functional capabilities of items.
Test is
similar to demonstration, but is more exacting, generally requiring specialized
test equipment/configuration/data/procedure in order to verify that the item
satisfies the requirement.
Analysis
is the use of established technical or mathematical models or simulations,
algorithms, or other scientific principles and procedures to provide evidence
that the item meets its stated requirements.
c)
In-process control
Critical
parameters shall be determined and monitored, checks performed during
production in order to monitor and if necessary to adjust the process to ensure
that the products conform to its specification. The control of the environment
or equipment may also be regarded as a part of in-process control.
Change
control
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11.2.7.
All changes that may affect product quality or reproducibility of the process
shall be formally requested, documented and approved by the relevant
department. The likely impact of the change of facilities, systems and
equipment on the product shall be evaluated, including risk analysis. The need
for, and the extent of, re-verification of machinery and equipment and
re-verification of process shall be determined.
11.3.
Guidelines on stability study and shelf-life of health supplements
Introduction
Stability
is an essential factor of quality in health supplements. It is determined by a
series of chemical, physical and microbiological tests conducted, namely to
ensure maintenance of the specifications of the finished product stored in the
established storage condition within the determined shelf-life.
Objective
This
guideline is intended to provide recommendations on the core stability study
required for products. Nevertheless it leaves sufficient flexibility to
encompass the variety of different practical situations that may be encountered
due to specific scientific considerations and characteristics of the products
being evaluated.
Design
11.3.1.
General
The
design of a stability study for the product should be based on the nature of
the product. It should take into account of the following:
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-
Specifications/Testing parameters;
- Testing
frequency;
-
Container closure system.
11.3.2.
Selection of batches
Stability
data should be provided for batches of the same formulation and dosage form in
the container closure system intended for marketing.
-
Stability data from at least two batches would be required, derived either from
pilot scale or primary scale or production scale.
- The manufacturing
process of batches used in stability studies should simulate that of production
batches and should be of the same quality as well as meet the same
specification as those batches intended for marketing.
-
Stability studies should be performed on individual strengths of the product
and/or type of container closure system in which the finished product is packed
unless bracketing/matrixing is applied as in the section “Reduced design”.
11.3.3.
Specification and testing parameters
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The list
of testing parameters is presented as a guide for the types of tests to be
included in a stability study as in the section “Tabulated list of stability
indicating parameters for health supplement”. The list of tests for each
product is not intended to be exhaustive, nor is it expected that every listed
test to be included in the design of the stability study protocol for a
particular finished product.
For a
combination product containing multiple active ingredients, although it may not
be necessary to assay all the active ingredients. It may be appropriate to
assay one, and in some cases, more than one active ingredient, or a surrogate
marker that is known to be susceptible to change under storage condition (such
as temperature and/or humidity) and is likely to influence the quality of the
combination product. A valid justification shall be submitted. For a product
containing ingredients without known marker(s), physical parameters may be used
as surrogate indicators during storage, when the use of such parameters can be
justified.
11.3.4.
Testing frequency
For
accelerated and real time stability studies, frequency of testing should be
sufficient to establish the stability profile of the finished product. At the
accelerated storage condition, a minimum of 3 time points, including the
initial and final time points, for example, 0, 3, and 6 months for a 6-month
study, is recommended.
The
frequency of testing at real time storage conditions should normally be every 3
months over the first year, every 6 months over the second year and annually
thereafter through the proposed shelf-life.
Table 1:
A typical testing frequency
Storage condition
Testing frequency;
Real
time
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Accelerated
0, 3
and 6 months
Reduced designs,
i.e., matrixing or bracketing, where the testing frequency is reduced or
certain factor combinations are not tested at all, can be applied, if
justified, as in the section “Reduced design”.
Where an
expectation exists that outcomes from accelerated studies are likely to
approach significant change criteria, i.e. parameters tested are out of the
specifications set, it is advised an increased testing should be conducted
either adding samples at the final time point or by including a fourth time point
in the study design.
If the
“significant change” occurs within the first 3 months’ testing at the
accelerated storage condition, a justification should be provided to address
the effect of short term excursions outside the label storage condition, e.g,
during shipping or handling. This justification can be supported, if
appropriate, by further testing on a single batch of the product for a period
shorter than 3 months but with more frequent testing than usual. It is
considered unnecessary to continue to test a product through the remaining
months when a “significant change” has occurred within the first 3 months, and
as such the shelf-life shall be based on real time data.
If
“significant change” occurs between 3 and 6 months’ testing at the accelerated
storage condition, shelf-life shall be based on real time data (often found in
preparations such as cream or grease which cannot be tested under accelerated
conditions).
11.3.5.
Storage conditions
In
general, HS as a finished product should be evaluated under its storage
conditions (with appropriate tolerances) that test its thermal stability under
recommended storage conditions and, if applicable, its sensitivity to moisture
or potential for solvent loss.
The
storage conditions and the lengths of studies chosen should be sufficient to
cover storage, shipment, and subsequent use, for example, after reconstitution
or dilution as recommended in the labeling.
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Table 2:
Common storage conditions
Type of container closure system/study
Storage condition
Products
in primary containers permeable to water vapor
30°C±2°C;
Relative humidity 75% ±5%.
Products
in primary containers impermeable to water vapor
30°C±2°C
Accelerated
studies
40°C±2°C;
Relative humidity 75% ±5%.
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□ Whether
any instability is seen;
□ Whether
data have also been provided under accelerated conditions;
□ The
type of container closure system.
Other
storage conditions are allowable, if justified. Examples would include:
□ Heat
sensitive products which should be stored under lower temperature condition
which will eventually become the designated long term storage temperature.
-
Products containing less stable active ingredients and formulations not
suitable for storage at elevated temperature will need real time stability
studies.
- When a
lower temperature condition is used, the 6 month accelerated testing should be
carried out at a temperature at least 150C above the expected actual
storage temperature (together with appropriate relative humidity conditions for
that temperature). For example, for a product to be stored long term under
refrigerated conditions, accelerated testing should be conducted at 25ºC ± 2ºC,
60% RH ± 5% RH. The designated real time testing conditions will be reflected
in the labeling and shelf-life (expiration date). Typical storage conditions
recommended for stability studies on products intended for storage in a
refrigerator as shown in Table 3 below.
□
Products which change physically or even chemically at lower storage temperature
conditions e.g., suspensions or emulsions.
Table 3:
Typical storage conditions recommended for products intended in a refrigerator
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Storage condition
Real
time
5°C±3°C
Accelerated
studies
25°C±2°C.
Relative humidity 60% ±5%
Data from
the accelerated stability studies can be used to evaluate the effect of
short-term excursions outside the label storage conditions such as during
shipping. The data from accelerated study and ongoing real time stability study
can be used to justify an interim extrapolated shelf-life. However, the actual
shelf-life should be based ultimately on the real time stability data at the
recommended storage conditions.
11.3.6.
Container closure system
Stability
testing should be conducted on the product packaged in the primary container
closure system proposed for marketing including, as appropriate, any secondary
packaging.
Finished
products packed in moisture-impermeable primary containers are not required to
be tested under high humidity conditions. Generally considered
moisture-impermeable containers include aluminium/aluminium blisters, High
Density Polyethylene (HDPE) or glass bottles fitted with metal or HDPE
closures.
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The
effect of high humidity on solid dosage forms packaged in containers permeable
to moisture should be supported by data and an indication, like “Keep in a dry
place or protect from moisture” should be added to the label. Examples of
moisture permeable containers include polycynyl chloride (PVC) blisters, low
density polypropylene (LDPE) bottles, glass or HDPE bottles when fitted with
polypropylene closures.
11.3.7.
Evaluation
A
systematic approach should be adopted in the presentation and evaluation of the
stability information, which should include, as appropriate, results from the
physical, chemical and microbiological tests. Any evaluation should consider
not only the assay, but also other appropriate test attributes. A recommended
presentation of the summary table of stability results appears as in the
section “Recommended presentation of the summary table of stability results”.
11.3.8.
Labeling
The
storage conditions that include temperature, light and humidity indicated on
the label should be based on the stability evaluation of the product. General
precautionary statements, such as “Protect from light” and/or “Store in a dry
place”, may be included, but should not be used to conceal stability problems
of the finished product. Specific instruction on storage condition should be
provided. Terms such as “ambient conditions” or “room temperature” should be
avoided.
Glossary
For the
purposes of this Appendix, the terms below shall be construed as follows:
1. Assay:
A test procedure for measuring or determining the quantity of active ingredient
or marker in a finished product.
2. Batch:
A defined quantity of starting material, packaging material or product produced
during a given cycle (in a single process or series of processes) and from a
specific formulation order, that is uniform in character and quality (the
essence of a manufacturing batch is its homogeneity). It may sometimes be
necessary to divide a batch into a number of sub-batches, which are later
brought together to form a final homogeneous batch.
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4.
Primary scale batch: A batch of product manufactured by procedure fully
representative of and simulating that to be applied to a full production scale
batch. A primary scale may comprise 10 - 100% of a full production scale.
5.
Production scale batch: A batch of product manufactured at production scale by
using production equipment in a production facility as specified in the
application.
6.
Specification: A list of tests, references to analytical procedures, and
appropriate acceptance criteria which are numerical limits, ranges, or other
criteria for the tests described. Specification is used as the basis for
quality assessment. “Conformance to specification” means that the product, when
tested according to the listed analytical procedures, will meet the acceptance
criteria. The set of criteria to which a substance, product or material at
stages of its manufacture should conform to shall be considered acceptable for
its intended use. Specifications are critical quality standards that are
proposed and justified by the manufacturer and approved by regulatory
authorities as conditions of approval.
7.
Stability study protocol: A document describing rationale, goals, methodology,
and statistical methods of the stability study which specifies the terms and
conditions under which the stability study must be conducted and managed.
8.
Stability studies: Real time and accelerated studies/testing undertaken on
primary batches according to a prescribed stability protocol to establish or
confirm the re-test period of a substance or shelf-life of a finished product.
-
Accelerated stability studies: Studies designed to increase the rate of
chemical degradation or physical change of a finished product by using
exaggerated storage conditions as part of the formal stability studies. Data
from these studies, in addition to long-term stability studies, can be used to
assess longer term chemical effects at non-accelerated condition and to
evaluate the effect of short term excursions outside the label storage
conditions such as might occur during shipping. Results from accelerated
testing studies are not always predictive of physical changes.
- Real
time stability studies: stability studies under the recommended storage
condition for the re-test period or shelf-life proposed (or approved) for
labeling.
9.
Storage condition: condition for intended storage of a finished product defined
on the container label based on the stability study.
Reduced
design
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Any
reduced design should have the ability to adequately predict the shelf-life. Before
a reduced design is considered, certain assumptions should be assessed and
justified. The potential risk when establishing a shorter shelf-life using a
reduced design should be considered due to the reduced amount of data collected
compared to data derived from a full design.
During
the course of a reduced design study, a change to full testing or to a less
reduced design can be considered if justification is provided and the
principles of full designs and reduced design studies are followed. Proper
adjustments should be made to the statistical analysis, where applicable, to
account for the increase in sample size as a result of the change. Once the
design is changed, full testing or less reduced testing shall be carried out
through the remaining time points of the stability study.
Bracketing
Bracketing
is the design of a stability schedule such that only samples on the extremes of
certain design factors, for example, strength, container size and/or fill, are
tested at all time points as in a full design. The design assumes that the
stability of any intermediate levels is represented by the stability of the
extremes tested.
Design
example
An
example of a bracketing design is given in Table 4 below. This example is based
on a product available in 3 strengths and 3 container sizes. In this example,
it demonstrated that the 15 ml and 500 ml high-density polyethylene container
sizes truly represent the extremes. The batches for each selected combination
should be tested at each time point as in a full design.
Table 4:
Example of Bracketing Design
Strength
50 mg
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100 mg
Batch
1
2
3
1
2
3
1
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3
Container
size (ml)
15
T
T
T
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T
T
100
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500
T
T
T
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T
T
T = Sample tested
Matrixing
Matrixing
is the design of a stability schedule such that a selected subset of the total
number of possible samples for all factor combinations would be tested at a
specified time point. At a subsequent time point, another subset of samples for
all factor combinations would be tested.
The
design assumes that the stability of each subset of samples tested represents
the stability of all samples at a given time point.
The
differences in the samples for the same finished product should be identified
as, for example, covering different batches, different strengths, different
sizes of the same container closure system, and possibly, in some cases,
different container closure systems.
When a
secondary packaging system contributes to the stability of the finished
product, matrixing can be performed across the packaging systems. Each storage
condition should be treated separately under its own matrixing design.
Matrixing should not be performed across test attributes. However, alternative
matrixing designs for different test attributes can be applied if justified.
Design
examples
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□ Example
of Matrixing Design on Time Points for a Product with two Strengths “One-Half
Reduction”
Time
point (months)
0
3
6
9
12
18
24
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Strength
S1
Batch 1
T
T
T
T
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T
Batch 2
T
T
T
T
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S2
Batch 1
T
T
T
T
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Batch 2
T
T
T
T
T
T
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At least 6 out of 12 time points
At least 4 out of 8 time points
□ Example
of Matrixing Design on Time Points for a Product with two Strengths “One-Third
Reduction”
Time
point (months)
0
3
6
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12
18
24
36
Strength
S1
Batch 1
T
T
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T
T
T
T
Batch 2
T
T
T
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T
T
S2
Batch 1
T
T
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T
T
T
T
Batch 2
T
T
T
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T
T
(T =
Sample tested)
At least 8 out of 12 time points
At least 6 out of 8 time points
□ Example
of Matrixing Design on Time Points for a Product with three Strengths
“One-Third Reduction”
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0
3
6
9
12
18
24
36
Strength
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Batch 1
T
T
T
T
T
T
T
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T
T
T
T
T
T
S2
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T
T
T
T
T
T
Batch 2
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T
T
T
T
T
S3
Batch 1
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T
T
T
T
T
T
Batch 2
T
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T
T
T
T
(T =
Sample tested)
At least 12 out of 18 time points
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Tabulated
list of stability indicating parameters of health supplement:
Testing parameters
Health supplement dosage form
Organoleptic characteristic
Assay
Hardness/ friability
Dissolution/ disintegration
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Viscosity
pH
Microbial content
Granules/ Particle size
Resuspendability
Oral powder
√
√
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√
√
Hard capsule
√
√
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√
√
√
Soft capsule
√
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√
√
Coated and uncoated tablet
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√
√
√
√
√
...
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√
√
√
√
√
...
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Suspension
√
√
√
√
√
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√
Solution
√
√
√
√
...
...
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Emulsion
√
√
√
...
...
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√
Granules
√
√
√
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√
√
Recommended
presentation of the summary table of stability results
Product
name:
……….
Storage
condition:
……….
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……….
Batch
No.
……….
Strength:
……….
Manufacturing
date:
……….
Container:
……….
...
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……….
Pack
size:
……….
Period
of the study:
……….
Testing parameters (as applicable)
Acceptance criteria
Testing frequency (months)
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3
6
9
12
18
24
…
Organoleptic
characteristic
...
...
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Strength
...
...
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Hardness
...
...
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Dissolution
...
...
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Humidity
...
...
...
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Microbial
content
...
...
...
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…
...
...
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Conclusion: ………………………………………………………………………………………...…
Prepared by
Checked
by
Approved
by
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11.4. Self-inspection
questionnaire
11.4.1.
Purpose
The
purpose of self-inspection is to sufficiently determine information and
evaluate the compliance with GMP in order to detect any shortcomings and
defects in the implementation of GMP and to recommend the necessary corrective
actions. The procedure for self-inspection should be documented, including a
detailed self-inspection checklist.
In case
of difference in production lines, product type and investment scale, each
manufacturer shall prepare and introduce a self-inspection checklist
appropriate to its condition. The preparation and application of a
self-inspection checklist shall be relevant to the objective and nature of the
inspection (initial or repeated, periodic or unscheduled, general or thematic
evaluation). This checklist shall be developed and/or adjusted according to the
following self-inspection questionnaire.
11.4.2.
Main contents
1)
General information about the Company
2)
Quality management
3)
Personnel and training
4)
Premises and equipment
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6)
Documentation
7)
Manufacturing and manufacturing process control
8)
Quality control
9)
Contract manufacture and analysis
10)
Complaints and product recalls
11)
Self-inspection
11.4.3.
Guidance on response to questions
- Regarding
open-ended questions, fill in the blank.
-
Regarding closed-ended questions, place a check mark “√” in the answer box.
...
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11.4.4.
Contents
1.
General information about the Company
-
Name/address: ………………………………………………………………
-
Telephone/fax: ……………………………………………………………
- Place
of manufacturing: …………………………………………….……….
-
Representative of the company/position: ………………………………………….…….
- Total
number of personnel: ……………………………………………………….
- Number
of personnel working in production areas: ………………………….…
-
Authorization of the National Regulatory Authority: …………………………
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-
Organzation chart: …………………………………………………………….
-
Training result: ………………………………………………………….
-
Diagrams of production areas (geographical premises; line arrangement; class of
cleanliness; layout, materials, bulk products, semi-finished products):
………………………………………………………………
- Diagram
of ancillary systems (air handling system, industrial water supply system,
wastewater treatment system, fire fighting system): ..…...
-
Manufacturing activities: product types, in-process controls, supplier
assessment: ………………………………….………..
- Quality
assurance system, quality control system: ………………………
-
Internal audit: …………………………………………………………...
2.
Self-inspection questionnaire
No.
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Applicable
Not applicable
Pass
Fail
I
Quality
management
...
...
...
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1
Whether
quality policies and commitments are determined, and formally promulgated by
competent persons.
2
Whether
a quality management system, including quality manual, procedures, resources
and organization structure concerned is established.
...
...
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3
Whether
managerial responsibilities are clearly documented.
4
Whether
arrangements are made for the manufacture, supply and use of the correct
starting and packaging materials.
...
...
...
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5
Whether
in-process controls are established and maintained according to the approved
procedures.
6
Whether
persons responsible for batch certification are assigned.
...
...
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7
Whether
before release, each batch is reviewed, certified and checked according to
procedures and specifications.
8
Whether
a plan for initial or periodic verification of critical steps of a
manufacturing process is prepared.
...
...
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9
Whether
critical steps or significant changes that affect product quality during the
manufacturing process are verified.
10
Whether
records covering manufacture, which enable the complete history of a batch to
be traced are prepared.
...
...
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11
Whether
there are adequate procedures for sampling, inspecting and testing starting
materials, intermediate, bulk, and finished products, and for monitoring
environmental conditions for GMP and checking measuring equipment.
12
Whether
quality control is sufficiently documented.
...
...
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13
Whether
product quality reviews are conducted according to GMP recommendations.
14
Whether
there are self-inspection/internal audit programs.
...
...
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II
Personnel
15
Whether
the organization chart is updated (by the time of self-inspection).
...
...
...
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16
Whether
the organization chart consists of the following (and the respective
quantity):
a
Production
department: ………………………………..… persons
...
...
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b
Quality
control department: ………………….… persons
c
Other
departments (please specify):
-
…………………………………………………. persons
-
…………………………………………………. persons.
...
...
...
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17
Whether
the head of Production Department and the head of Quality Control Department
are independent of each other.
18
Whether
these key posts are occupied by full-time personnel.
...
...
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19
Information
about the head of the Production Department:
-
Knowledge (GMP, manufacturing, etc.): …………..………………….
-
Qualifications: ………………………….
- Skills:
……………………………………………………
-
Experience (manufacturing, manufacturing management): ……..
...
...
...
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20
Information
about the head of Quality Control Department:
-
Knowledge (GMP, testing, etc.): …………..………………….
-
Qualifications: ………………………….
-
Skills: ……………………………………………………
-
Experience (testing, testing management): ……………………………………………………
...
...
...
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21
Organization
and operation of the Production Department:
a
Line-based
(and the respective quantity on each line):
...
...
...
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- Line
A: ……………………………………………………
- Line
B: ……………………………………………………
b
Step-based
(and the respective quantity required for each step):
...
...
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-
Preliminary processing: ……………………………………………………..
-
Processing: …………………………………………………..
-
Shaping: ………………………………………………….
- Primary
packaging: ……………………………………………
-
Secondary packaging: ……………………………………………
...
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c
Combined
line and step (and the respective quantity):
-
Preliminary processing line A: ……………………………………………………
-
Processing line B: ……………………………………………………
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22
Organization
and operation of the Quality Control Department [arranged by tests (chemical,
physical, physicochemical or microbiological test); by items (materials,
packaging, bulk or finished products); by activities (standard
establishment/verification, application registration, testing, stability
monitoring, production condition verification/assessment, inspection,
supervision), etc.] and respective quantity of each unit:
-
……………………………………………………………...
23
In-process
control personnel belonging to:
...
...
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- Or
Production Department (and quantity): ……………………..
24
Job
description of:
- Head
of Production Department: ………………………………….
- Head
of Quality Control Department: ……………………
- Head of
another department: ………………………
...
...
...
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25
Job
description(s) of each (group of) personnel:
- Group
…: ………………………………………………….
- Group
…: ………………………………………………….
...
...
...
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Whether
all personnel undergo initial and regular health examinations and medical
records are sufficiently retained.
27
Whether
all personnel receive training in GMP
...
...
...
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Whether
all personnel receive training in SOPs, relevant professional operations and
knowledge.
29
Whether
new personnel training procedures are available.
...
...
...
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Whether
the training is provided according to the approved plan, programme and
contents.
31
Whether
trainers have knowledge and experience and have provided training in GMP
...
...
...
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Whether
after each training course, results and effectiveness of training are
assessed and all training records are retained.
III
Premises
and equipment
...
...
...
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Premises
33
Whether
the establishment manufactures products containing sensitizing materials such
as penicillins, hormones or live microorganisms or products intended for
external use.
...
...
...
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Whether
dedicated facilities are available for the production of these products.
35
Whether
production, testing, storage and ancillary areas are appropriately located
and designed.
...
...
...
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Whether
premises are well maintained.
37
Whether
design drawings (general, detailed) are updated.
...
...
...
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Whether
relevant parameters are verified and assessed again after changes are made.
39
Whether
there are adequate toilets, which are well ventilated and separated from
other areas, and do not have direct access to production and storage areas.
...
...
...
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Whether
risk or condition that insects or other animals access and harbor is
available.
41
Whether
access to relevant areas is restricted to authorized personnel.
...
...
...
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Production
areas
42
Whether
production lines are designed and arranged following one-way rule, which
facilitates the movement of materials/intermediate products/bulk
products/packaging/finished products, personnel and residues/scraps/wastes to
avoid mix-ups, contamination or cross-contamination.
...
...
...
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Whether
changing rooms are directly connected to but separated from production areas.
44
Whether
suitable locker facilities are provided at appropriate locations for the
storage of employees’ clothing and personal property.
...
...
...
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Whether
production areas provide adequate space for the
installation/maintenance/repair of equipment, production operations and easy
cleaning.
46
Whether
areas are designated for the temporary storage of materials after being dispensed
and in-process products under appropriate conditions and provide adequate
space.
...
...
...
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Whether
pipework, light fittings, ventilation points and other facilities shall be
appropriately sited to facilitate cleaning.
48
Whether
areas where open materials or products are exposed to the environment with
strict sanitary conditions (hereinafter referred to as “clean areas/zones”)
are well ventilated, smooth and designed in a manner that permits easy and
effective, and does not build up or shed particulate matter.
-
Information about materials for walls/floors/ceilings: ….…/……/…..
-
Information about filter classes/pressure difference: ………/….……
...
...
...
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49
Whether
there is any peeling paint or crack in these areas.
50
Whether
separate spaces are created for cleaning of production equipment to avoid
contaminating clean areas.
...
...
...
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51
Whether
areas where for containers for waste generated during the manufacturing
process and waste routes are appropriately defined to avoid contaminating
products and clean areas.
52
Whether
wastewater is collected by anti-syphon traps.
...
...
...
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53
Whether
open channels are shallow enough to facilitate cleaning
54
Whether
parameters lighting (a), temperature (b), humidity (c) and ventilation (d)
are established, assessed and maintained in a manner that is appropriate to
steps of each line:
a)
Information about Line 1:
...
...
...
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a
b
c
d
Toilet
and changing clothes for the first time
...
...
...
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Changing
clothes for the second time
...
...
...
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Shaping
and primary packaging
...
...
...
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b)
Information about Line 2: ……………………………………
55
...
...
...
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Clearly
specify control measure: ………………………
56
Whether
a limit is imposed on the abovementioned parameters and measures to be taken
if such limit is exceeded.
...
...
...
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Whether
the measurement of particles in clean zones is carried out after completing the
construction of premise and installation of equipment, and are carried out at
regular intervals:
-
Quantity/m3: … (particles ≥0.5 µm); … (particles ≥5.0 µm)
-
Measurement frequency: ……………………………………………
58
Whether
special requirements are imposed on controlled areas of facilities
manufacturing products at risk of generating microorganisms, such as soft
pellets, syrups, preparations extracted from herbal ingredients, etc.
-
Clearly specify control measure: ……………………
...
...
...
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-
Testing frequency: ……………
59
Specify
dust control measures taken in production areas or products that may generate
dust: …………………………………………
...
...
...
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Storage
areas
60
Whether
there are separate areas for storage of starting materials, packaging
materials and finished products, which provide adequate space and are under
appropriate temperature and humidity conditions.
...
...
...
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Whether
there are separate areas for the receipt, quarantine, storage and release in
the abovementioned areas.
62
Whether
if special storage conditions are required (temperature, humidity or
ventilation), these conditions are monitored using calibrated equipment.
Temperature:
…-… 0C; Humidity: …-… %; Recording frequency: …
...
...
...
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63
Whether
there are separate areas for isolation and locks for printed packaging
materials, materials/rejected products, residues/scrap, recalled/returned
products.
64
Whether
there are starting material sampling areas, which satisfy sanitary
requirements and manage the risk of cross-contamination.
...
...
...
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65
Whether
there are separate areas for storage of crude natural materials, materials or
flammable substances.
Testing
areas
...
...
...
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66
Whether
there are laboratories separated from production areas.
67
Whether
there are microbiological laboratories, which meet design requirements.
...
...
...
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68
Whether
working rooms are appropriately located and provide sufficient space.
Information
about rooms and respective area: ………
69
Whether
there are sufficient equipment and utensils that basically meet requirements
for testing of materials, products, assessment/monitoring of
environment/production conditions and that undergo assessment prior to use.
List
main analytical equipment: ……………………
...
...
...
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Ancillary
areas
70
Whether
ancillary areas are separated from production, testing and storage areas.
...
...
...
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71
Whether
ancillary areas are located and designed in a safe and sanitary manner.
...
...
...
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72
Whether
there is sufficient production equipment appropriate to current production line(s).
List
current main production equipment: ……………………
...
...
...
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Whether
such equipment is designed with appropriate power.
74
Whether
auxiliary parts of production equipment such as exhaust pipe of capsule
filling machine, static drying chamber, motor/drive, etc. are appropriately
covered and cleaned at regular intervals.
...
...
...
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Whether
surface of equipment, utensils, pipes and filters in direct contact with
materials and products is made of inert materials that are not additive and permit
easy cleaning.
76
Whether
equipment is installed and located in a space wide enough for the operation,
cleaning or maintenance.
...
...
...
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Whether
material/product pipes/valves/exhaust pipes (fixed or diassembled) are designed
and installed according to sanitary requirements.
78
Whether
fixed pipes are installed inclined to avoid the stagnation of rinsing water.
...
...
...
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Whether
valves intended for closing/opening flow of materials/liquid products are
used.
If
available, specify microbiological contamination control measure: …………
80
Whether
fixed pipework is clearly labeled to indicate the contents and direction of
flow.
...
...
...
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81
Whether
equipment is evaluated and tested prior to use and periodic maintenance.
82
Whether
balances and other measuring equipment of an appropriate range and precision
are available and verified/calibrated as prescribed.
...
...
...
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83
Whether
defective equipment is removed from production areas or covered to avoid contamination
or clearly labeled as unusable in case of failure to move.
Utility
system
...
...
...
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84
Whether
ancillary utility system is designed and installed in a manner that ensures integrity
of materials, in-process products and finished products.
List
current utilities: ……………………
85
Whether
maintenance and cleaning programme is designed for each ancillary system and
complied with.
...
...
...
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86
Whether
there are standards and written procedures for the operation of systems,
sampling and monitoring.
87
Whether
defined actions are taken to handle the cases in which the standards are not
met.
...
...
...
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Air
handling system
88
Whether
air handling and supply system satisfies temperature, humidity and
ventilation requirements.
...
...
...
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89
Whether
system diagram is located at locations that permit easy monitoring and
handling in case of incidents.
90
Whether
pipework is clearly labeled to indicate the direction of air flow.
...
...
...
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91
Whether
exhaust gas is filtered and/or appropriately handled before being released
into the environment.
92
Whether
the air supply system is periodically fumigated in areas at high risk of
causing microbiological contamination to products.
...
...
...
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93
Whether
pipework is made of materials impermeable to disinfectants.
94
Whether
the ability to filter air is appropriate to the expected cleanliness level
and minimize the effect of contamination and cross-contamination on
operations.
...
...
...
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95
Specify
design value, warning/action limits and recording/monitoring frequency
corresponding to the parameters: filter class (a), pressure difference
before/after intermediate/final filtration (b), pressure difference between
rooms/halls in areas which have various cleanliness levels or require various
controls (c) number of air exchanges (d), room temperature/humidity (dd) of
the following areas:
a
Warehouses
storing materials and packaging that only require air ventilation: ……
...
...
...
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b
Warehouses
storing materials and packaging that require temperature/humidity control: ….
c
Preliminary
processing areas: ………………………………………………
...
...
...
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d
Processing
and primary packaging areas (open materials/products):
……………………………………………………………….……
dd
Secondary
packaging areas and finished product warehouses: …………………..
...
...
...
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e
Microbiological
laboratories and sampling areas: ………………
g
Physicochemical
laboratories and sample retention rooms: …………………..
...
...
...
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96
Whether
air handling and supply system is verified prior to use, periodic assessment
is carried out, records are made and documents are retained.
97
Whether
HEPA filter is installed for air supplied to rooms/areas presenting high risk
to materials and products.
...
...
...
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98
Whether
there are appropriate monitoring and control measures for ensuring integrity
of HEPA filters.
99
Whether
pre or intermediate filters are periodically cleaned or appropriately
replaced.
...
...
...
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Water
treatment system
100
Whether
water treatment and supply system is appropriate to its intended use.
...
...
...
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101
Whether
water used for cleaning and preliminary processing of natural raw materials
satisfies standards for domestic water.
102
Specify
sources of domestic water used by plants (well water, drilled well water, tap
water, etc.): ………………………
...
...
...
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103
Whether
water used for processing (and rinsing equipment and utensils in clean areas)
satisfies standard for drinking water or standard for pure water according to
Vietnam’s pharmacopoeia.
104
Specify
the technology for treating such kind of water: ………………………
...
...
...
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105
Whether
pipework is clearly labeled to indicate the name and direction of flow.
106
Whether
pipework is made of appropriate materials that are not reactive or additive
to such an extent that it will affect the quality of water.
...
...
...
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107
Specify
materials for producing pipes conveying drinking water or pure water used for
producing products at high risk of causing microbiological contamination:
……………………….
108
Whether
there are programmes and plans for sampling and water quality inspection.
...
...
...
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109
Whether
limit on microbiological and physicochemical criteria are imposed and
controlled appropriately and effective measures are taken if such limit is
exceeded.
Compressed
air system
...
...
...
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110
Whether
the establishment uses compressed air for production, which:
a
comes
into contact with products (extracting, packing, etc.) and/or clean utensils
...
...
...
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b
or only
supports production (lifting, etc.) and does not come into contact with
products.
111
Whether
compressed air in contact with products is periodically checked for:
...
...
...
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a
Oil
streaks
b
Particles
...
...
...
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c
Microbiological
limit
d
And
humidity, when necessary
...
...
...
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112
Whether
system diagram is located at locations that permit easy monitoring and
handling.
113
Whether
compressed air is handled and filtered through appropriate filters.
...
...
...
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114
Whether
there are compressed air monitoring and assessment programs.
115
Whether
this system has its safety verified as prescribed
...
...
...
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Water
vapor production system
116
Whether
the establishment that uses water vapor for production, which:
...
...
...
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a
comes into
contact with product surface or surface of processing utensils in contact
with products;
b
or only
supports production (heating, etc.) and does not come into contact with
products.
...
...
...
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117
Clearly
specify water used for creating water vapor:
a
For
creating clean water vapor: …………………………………………
...
...
...
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b
For
boilers for heating purpose: ………………………………
118
Whether
the vapor system has its safety verified as prescribed
...
...
...
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119
Whether
pipes are made of properly treated stainless steel.
Wastewater
treatment system
...
...
...
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120
Whether
wastewater treatment system is designed, constructed and operated in a manner
that is appropriate to the nature of wastewater and waste generated during
production and testing.
121
Whether
wastewater treatment system is confirmed by the supervisory environment
authority.
...
...
...
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Fire
fighting system
122
Whether
fire fighting system is intended for plants.
...
...
...
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123
Whether
there is a relevant regulatory authority’s effective confirmation of
operation of the fire fighting system.
IV
Sanitary
conditions and sanitation control
...
...
...
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Personnel
124
Whether
personnel undergo pre-employment medical examination and examination is done
periodically.
...
...
...
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125
Whether
personnel are trained in personal hygiene.
Specify
training documents and SOP number: …………
126
Whether
sufficient soap and hand drying/washing facilities are provided in necessary
areas.
...
...
...
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127
Whether
sufficient protective garments necessary and suitable for activities are
provided.
128
Whether
personnel in clean areas wear clean clothes, shoes/sandals and hats.
...
...
...
Hãy đăng nhập hoặc đăng ký Thành viên
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129
Whether
personnel working in microbiological laboratories and in clean areas wear
gloves when coming into direct contact with materials and products.
130
Whether
protective garments are appropriately collected and washed in sanitary areas.
...
...
...
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131
Whether
washing intervals are defined to make sure they are not left unused for an
excessive amount of time.
132
Whether
any personnel suffering illness or open wound is found still engaging in
production at stages that may affect product quality.
...
...
...
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133
Whether
access to production areas and other prohibited areas is restricted to
authorized personnel.
134
Whether
visitors are given information about personal hygiene and the prescribed
protective clothing, and are closely supervised.
...
...
...
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135
Whether
any person is found eating, chewing or drinking or bringing/putting foods,
drinks or personal property in this area.
Premises
...
...
...
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136
Whether
there is a pest control programme.
137
Whether
there are measures/agents for cleaning/killing insects, which exert adverse
effects on products.
...
...
...
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138
Whether
insects or other animals are found accessing or harboring in production,
storage or testing areas.
139
Whether
there are premise cleaning procedures, which define responsibilities,
schedules, methods, cleaning agents, utensils, etc. appropriate to each area
(clean, controlled or exterior, etc.) and procedures are complied with.
...
...
...
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140
Whether
any dust is found in production rooms in clean areas under non-operating
conditions.
141
Whether
cleaning intervals are defined to make sure they are not left unused for an
excessive amount of time.
...
...
...
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142
Whether
wastewater collection and treatment system satisfies sanitary requirements or
wastewater treatment contract satisfies applicable regulations on
environmental protection.
Equipment
and utensils cleaning
...
...
...
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143
Whether
there are separate rooms for cleaning mobile equipment, removable parts and utensils
to avoid contaminating cleaned rooms/equipment/utensils.
144
Whether
cleaned equipment and utensils are stored in a clean and dry condition.
...
...
...
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145
Whether
vacuum or wet cleaning method with lint-free towel/cloth is to be preferred.
146
Whether
compressed air and brushes are used in clean areas.
...
...
...
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147
Whether
quality of compressed air is controlled in clean areas (particles) and compressed
air comes into direct contact with foods in clean areas (oil streaks).
Clearly
specify measures and implementing frequency: ……………………
...
...
...
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Whether
a list of cleaning agents suitable for cleaning premises and equipment is
compiled.
149
Whether
water used for cleaning complies with applicable regulations.
...
...
...
Hãy đăng nhập hoặc đăng ký Thành viên
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Whether
there are cleaning procedures intended for each type of production equipment,
which define responsibilities, cleaning methods, agents, utensils and intervals,
etc. and procedures are complied with.
151
Whether
these procedures permit effective cleaning of equipment and toughest stains.
Whether
records of assessment of cleaning effectiveness of these procedures are
retained.
...
...
...
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152
Whether
cleaning intervals are defined to make sure equipment and utensils are not
left unused for an excessive amount of time.
153
Whether
microbiological limits are imposed on the system (pumps, pipes, couplings,
filters, valves, hoses, etc.) for distributing water, materials/liquid
products.
...
...
...
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154
Whether
an operation and cleaning record is made for each equipment.
Materials,
additives and food processing aids
...
...
...
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155
Whether
materials are purchased from approved suppliers.
156
Whether
the standard to be satisfied by suppliers includes the following:
...
...
...
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a
Manufacturer’s
quality management system;
b
Specifications
for materials (appropriate to expected quantity of final products);
...
...
...
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c
Requirements
for packaging, labeling, storage and quality control
157
Whether
every material container in warehouses is labeled as quarantined, sampled,
released or rejected and put in separate areas.
...
...
...
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158
Whether
each batch of materials received is sampled, checked and tested according to
specifications to consider whether to release or reject.
159
Specify
measures for assuring identity of the contents of each material container,
including the container from which samples are not taken:
...........................................................
...
...
...
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160
Whether
primary packaging is clean prior to use.
Specify
measures: ……………………………………
161
Whether
cut labels and loose materials are stored in separate containers with
identification labels.
...
...
...
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162
Whether
appropriate control measures are adopted to avoid mix-ups when dispensing or using
printed materials (especially those containing the products with the same
name but different contents) or batch numbers and expiry dates are assigned
upon packing or inkjet printing (especially the additional amount).
163
Whether
material containers are cleaned before being transported to a weighing room.
...
...
...
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164
Whether
materials are divided in clean areas and appropriately labeled.
165
Whether
any material that is not approved by QA/QC departments or has reached its
expiry or retest date is dispensed.
...
...
...
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166
Whether
materials are dispensed using the FEFO or FIFO method.
167
Whether
the weighing and dispensation are controlled in an independent manner.
...
...
...
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168
Specify
measures for controlling cross-contamination occurring during the processing
of weighing, dispensing or collecting samples of materials: ………………………
169
Whether
materials dispensed for each batch are kept together.
...
...
...
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170
Whether
the dispensation of additional materials or receipt of residual products is
approved by the head of the Production Department or Quality Control
Department and operations are carried out in the same manner as materials are
initially dispensed.
V
Documentation
...
...
...
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Whether
the establishment has the following basic documents about
171
Personnel
and training.
...
...
...
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172
Premises
and results of manufacturing environment monitoring and assessment.
173
Production
equipment and results of assessment and testing thereof.
...
...
...
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174
Cleaning
and cleaning procedure assessment.
175
Materials
and supplier assessment.
...
...
...
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176
Receipt,
storage and dispensation of materials and finished products.
177
Manufacturing
and manufacturing process assessment.
...
...
...
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178
Quality
control
179
Change
control
...
...
...
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Pro tại đây để xem toàn bộ văn bản tiếng Anh.
180
Product
distribution records
181
Complaint
handling and product recalls
...
...
...
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Pro tại đây để xem toàn bộ văn bản tiếng Anh.
182
Contract
manufacture and analysis
183
Environmental
safety assurance and fire fighting
...
...
...
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184
Self-inspection
Documentation
...
...
...
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185
Whether
documentation is prepared, checked/reviewed, approved, dated and signed by
appropriate and authorized person.
186
Whether
document is laid out according to standard design(s) and has clear and
unambiguous contents.
...
...
...
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187
Whether
documentation is updated and reviewed and remains effective.
188
Whether
effective dispensation and recall measures are in place to make sure old
versions are not used.
Clearly
specify such measures: ……………………………………………………..
...
...
...
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189
Whether
personnel are trained in amendments before application.
190
Whether
the recording or entry of data is immediately carried out after performing
each activity.
...
...
...
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191
Whether
any correction, alternation or erasure aimed at blotting out original
information is found.
192
Whether
any relevant documentation (production and quality control) is retained for
at least 01 year after the expiry date of the finished product.
...
...
...
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193
Whether
documentation is retained in a manner that enables the comparison and if
necessary, complete history of a batch to be traced.
Quality
control documents
...
...
...
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194
Whether
the Quality Control Department has the following basic documents, including
but not limited to:
a
Analyst
training records.
...
...
...
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b
Water
records.
c
Specifications
for starting materials.
...
...
...
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d
Specifications
for packaging materials.
dd
Specifications
for finished products.
...
...
...
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e
Records
of verification of analysis procedures (if any) and documents about test
methods.
g
Procedures
for taking samples of raw materials, natural raw materials, packaging
materials and intermediate, bulk and finished products.
...
...
...
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h
Records
of sampling and results of monitoring/inspection (packaging and some certain types
of materials), analysis (intermediate products), testing (materials, bulk
products, finished products): Sample collection form, analyst’s book,
analysis report, test report, original test report, etc.
i
Procedures
for and records of the calibration/inspection of equipment/measuring
instruments and analytical equipment.
...
...
...
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k
Records
of stability monitoring and evaluation of trends in product quality.
Specifications
...
...
...
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Specifications
for natural materials
195
Whether
the establishment uses natural materials.
...
...
...
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196
Whether
information about natural materials includes:
a
...
...
...
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b
Origin
(cultivation/harvesting area).
c
...
...
...
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d
Storage
condition and expiry date (if any).
dd
...
...
...
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197
Whether
there are sufficient procedures for determining each type of natural
material.
198
...
...
...
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Pro tại đây để xem toàn bộ văn bản tiếng Anh.
a
Pictorial
demonstration/description and identification of active ingredient(s) or
marker(s) (if any).
b
...
...
...
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c
Limit
tests:
...
...
...
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- Loss
on drying.
...
...
...
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-
Mycotoxins, microfungi.
...
...
...
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- Radioactivity.
d
...
...
...
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Specifications
for other starting materials and packaging materials
199
...
...
...
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200
Whether
specifications for materials include:
a
...
...
...
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b
Name of
the manufacturer and supplier.
c
...
...
...
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d
Qualitative
requirements and acceptance limits.
dd
...
...
...
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e
Residual
solvents in extracts or finished products.
g
...
...
...
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Pro tại đây để xem toàn bộ văn bản tiếng Anh.
h
A
specimen of printed materials.
201
...
...
...
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Specifications
for intermediate and bulk products
202
...
...
...
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Pro tại đây để xem toàn bộ văn bản tiếng Anh.
203
Whether
specifications (tests and acceptance limits) established for these products
are appropriate to starting materials or respective finished products.
...
...
...
Hãy đăng nhập hoặc đăng ký Thành viên
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204
Whether
adequate specifications are established for every finished product.
205
...
...
...
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Pro tại đây để xem toàn bộ văn bản tiếng Anh.
a
Name, dosage
form, package details and code.
b
...
...
...
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c
Physical
appearance.
d
...
...
...
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dd
Qualitative
requirements and acceptance limits.
e
...
...
...
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Pro tại đây để xem toàn bộ văn bản tiếng Anh.
g
Bacterial
contamination limits.
h
...
...
...
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i
Tests
specific to each dosage form: Dissolution, hardness, friability, viscosity,
pH, etc.
k
...
...
...
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Pro tại đây để xem toàn bộ văn bản tiếng Anh.
l
Storage
condition and expiry date.
m
...
...
...
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Pro tại đây để xem toàn bộ văn bản tiếng Anh.
Production
documents
206
...
...
...
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List
current products (for each specification): ……………
207
Whether
each production procedure is evaluated prior to production to ensure
suitability and reproducibility of the procedure.
...
...
...
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Pro tại đây để xem toàn bộ văn bản tiếng Anh.
Whether
documents are up to date and closed managed to make sure ineffective old
versions are not used.
Original
formula and processing/packaging instructions
...
...
...
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Pro tại đây để xem toàn bộ văn bản tiếng Anh.
Whether
there are sufficient original formulas and processing instructions for each
finished product batch size.
210
Whether
processing instructions are stated in a clear, sufficient and stepwise
manner.
...
...
...
Hãy đăng nhập hoặc đăng ký Thành viên
Pro tại đây để xem toàn bộ văn bản tiếng Anh.
Whether
adequate information or requirements for each operation or stage are
available:
a
Quantity
of each material added;
...
...
...
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Pro tại đây để xem toàn bộ văn bản tiếng Anh.
Name of
equipment, code, reference to SOP, parameters required (speed, times, etc.);
c
Patterns,
utensils (type, size), reference samples of printed materials;
...
...
...
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Pro tại đây để xem toàn bộ văn bản tiếng Anh.
Sampling,
product quality control (tests, reference to test methods), if any;
dd
Theoretical
yields of each step….
...
...
...
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Batch
processing/packaging records
212
Whether
there are sufficient batch processing/packaging records for each finished
product batch size.
...
...
...
Hãy đăng nhập hoặc đăng ký Thành viên
Pro tại đây để xem toàn bộ văn bản tiếng Anh.
Whether
records are prepared according to original formula and processing/packaging
instructions, and standard design for each dosage form and pack size.
214
Whether
batch records are prepared according to current versions of the production
procedure.
Justification:
……………………………………………………
...
...
...
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215
Whether
records are made after carrying out each operation and completed after the
end of each step.
216
Whether
each result of operations carried out or actual value of each batch is recorded
in accordance with the original formula and processing/packaging
instructions.
...
...
...
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217
Whether
a batch record states:
a
Name,
code, content, dosage form, product specification, batch size/number and
expiry date.
...
...
...
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Pro tại đây để xem toàn bộ văn bản tiếng Anh.
b
Name, code,
number/weight, batch number, number of test report/acceptance report of every
material dispensed
c
Sufficient
about starting/ending time and signature of the person carrying out the
activities/inspection.
...
...
...
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d
Reconciliation
between theoretical/actual yields of residual products/scraps and rate % as
requested
dd
Reconciliation
(received, used/defective/returned quantities) and specimen of primary
packaging, printed materials
...
...
...
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e
Results
of inspection carried out before/during/after the manufacturing process of
each step
g
Report
on test of finished products prior to release
...
...
...
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218
Whether
activities performed differently from standard procedure (batch size, quantity,
temperature, moisture content, times, etc.) are accepted by the heads of the
Production/Quality Control Departments.
219
Whether
deviations (moisture content, content, weight, quantity, etc.) listed and
used when assessing batch records and monitoring quality trend.
...
...
...
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Standard
Operating Procedures (SOPs) and records
220
Whether
SOPs are established for routine activities such as personal hygiene,
protective garment changing, operation of production equipment, sampling,
etc.
Number
of SOPs (attached to the List): …………………………
...
...
...
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221
Whether
training in SOPs is provided to relevant personnel.
222
If a
SOP is revised, whether the old SOP is discarded and personnel are
re-trained.
...
...
...
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223
Whether
SOPs are available at locations that permit easy reference.
224
Whether
a SOP intended for the receipt includes the following basic receipt
requirements:
...
...
...
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Pro tại đây để xem toàn bộ văn bản tiếng Anh.
a
Name,
code, batch number, number/quantity of materials.
b
Supplier’s
name and manufacturer’s name.
...
...
...
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c
Packaging
state and storage conditions upon delivery/receipt.
d
Check
information against invoice/delivery note.
...
...
...
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Pro tại đây để xem toàn bộ văn bản tiếng Anh.
e
Date,
signature and name of the person who delivers/receives.
225
Whether
materials and finished products are released by taking the following steps:
...
...
...
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Pro tại đây để xem toàn bộ văn bản tiếng Anh.
a
Receipt,
control
b
Labeling,
quarantine
...
...
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Pro tại đây để xem toàn bộ văn bản tiếng Anh.
c
Sampling,
check, testing
d
Release
(or rejection), status labeling, storage awaiting for release (or isolation)
...
...
...
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226
Whether
the following basic requirements are imposed on release of a finished product
batch:
a
Review of
records and conformity of results of in-process testing.
...
...
...
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b
Finished
product results.
c
Production
conditions (rooms, equipment).
...
...
...
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d
Other
activities and deviations (if any).
227
Batches
are numbered so that:
...
...
...
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a
Whether
each batch of materials, in-process products and finished products is
identified with a specific batch number and same batch numbers will not be
repeatedly used.
b
Whether
the traceability of any batches, including those containing residual products
or reprocessed products is permitted.
...
...
...
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Pro tại đây để xem toàn bộ văn bản tiếng Anh.
c
Whether
the batch number allocation shall be immediately recorded (in blank
documents, material dispensation notes, labels, when inkjet printing, etc.),
including batch size.
VI
Manufacturing
...
...
...
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General
228
Whether
all activities related to the manufacturing of a batch of finished products
are performed according to procedures, documented and made into a batch
record.
...
...
...
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229
Whether
the receipt of residual or reprocessed products or activities beyond the
procedure are accepted by the heads of the Production/Quality Control
Departments.
230
Whether
the rate % of receipt, maximum retention period and tests if required are
determined.
...
...
...
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231
Whether
these activities are documented, batches of these products or these products
are assigned a separate batch number for the purposes of monitoring and
additional testing.
232
Whether
different products are manufactured simultaneously or continuously in a room.
If
available, please specify:
..................................................................
...
...
...
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233
Whether
cross-contamination or mix-ups may occur upon performing the abovementioned
manufacturing operation.
Specify
control measures, if available:
...............................................
...
...
...
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234
Whether
there is a record of checks, and the results obtained before an operation
begins.
235
...
...
...
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Pro tại đây để xem toàn bộ văn bản tiếng Anh.
a
Status
of the room (line clearance performed, cleaned, meeting temperature and
humidity requirements, etc.);
b
...
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c
Patterns,
parts, utensils, sieve cloth, mortars and pestles, etc. (proper type,
cleaned);
d
...
...
...
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236
Whether
all dispensed materials and packaging, and intermediate and bulk products are
closely packaged, labeled and stored under appropriate storage conditions.
237
...
...
...
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238
Whether
the name and batch number of the product are displayed using signs at each
packaging line.
239
...
...
...
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240
Whether
in-process controls include, but are not limited to:
a
...
...
...
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b
Personal
hygiene control and compliance with manufacturing procedures by personnel.
c
...
...
...
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d
Tablet:
weight and difference, hardness/friability, disintegration, etc.;
dd
...
...
...
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e
Bags,
packs, bottles: proper packaging, batch number, expiry dates, closeness,
volume and difference, etc.
g
...
...
...
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241
Whether
tested samples are collected, labeled and transported to a location awaiting
for destruction.
242
...
...
...
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243
The
checks include, but are not limited to, the following:
a
...
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b
Line
clearance
244
...
...
...
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245
Whether
materials returned to stock are closely packaged, labeled and entered into
batch record and monitoring book (card).
246
...
...
...
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247
Whether
in the event of a significant variation, steps are taken to prevent release or
further processing of the batch, until an appropriate investigation is made.
248
...
...
...
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Cross-contamination
prevention
249
...
...
...
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a
Samples
are taken during the cleaning or when the cleaning has not been performed;
b
...
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c
Rooms,
equipment and utensils intended for producing/weighing/taking samples have
not been cleaned;
d
...
...
...
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dd
The
systems for filtering, supplying/capturing air and controlling pressure
difference fail to comply with regulations;
e
...
...
...
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250
Specify
cross-contamination prevention or control measures that have been taken:
…………….
VII
...
...
...
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251
Whether
there is a Quality Control Department with sufficient personnel and appropriate
equipment.
252
...
...
...
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a
Approve
specifications for materials, packaging and in-process products and finished
products;
b
...
...
...
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c
Assess
suppliers and consider deciding to accept materials and packaging;
d
...
...
...
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dd
Standardize
conditions for production, storage, assessment and monitoring;
e
...
...
...
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g
Assess
batch records and decide to release finished products;
h
...
...
...
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253
Whether
the abovementioned activities are performed according to SOPs, procedures or
protocol and sufficiently documented.
254
...
...
...
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255
Whether
a contract analysis is undertaken to conduct any special test.
Specify
names of the tests and respective laboratories: ……
...
...
...
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Sampling
256
Whether
samples are taken at locations free from contamination or
cross-contamination, by designated persons wearing appropriate clothes and
maintaining an appropriate degree of personal hygiene, and according to a
procedure.
...
...
...
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Whether
different batches (of a material) are considered as separate for sampling.
258
Whether
samples are sufficient and representative of the number of material and
product containers.
...
...
...
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Whether
material and product containers from which samples have been drawn are
identified.
260
Whether
samples are packaged, labeled and stored under appropriate conditions to make
sure their status quo is maintained and they are stored for a given period of
time.
...
...
...
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Check/testing
261
Whether
methods for testing parameters of every material, bulk product and finished
product are assessed at least in terms of their specificity and accuracy.
...
...
...
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Whether
methods for testing parameters of every finish product are expected to be
submitted in the marketing authorization dossier or have been accepted by the
licensing authority as prescribed.
263
Whether
all testing operations are carried out according to approved methods.
...
...
...
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Whether
reagents and standard solutions are prepared, labeled and stored as
prescribed.
265
Whether
results of operations carried out are documented and retained for a given
period of time.
...
...
...
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Stability
monitoring
266
Whether
programmes or protocols are designed, samples are taken and retained, and
tests are conducted to monitor the stability of products in order to
determine their shelf-life.
...
...
...
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Whether
programmes or protocols are designed, samples are taken and retained, and
tests are conducted to monitor the stability of products after being sold on
the market.
268
Whether
stability protocols are established in accordance with regulations.
...
...
...
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Whether
results of operations carried out are documented, processed and retained.
VIII
Contract
manufacture and analysis
...
...
...
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Whether
the establishment undertakes contract manufacture.
Specify
products and respective manufacturing steps: ………
271
Whether
the Contract Acceptor has its manufacturing competency assessed
to carry out the contracted operations correctly in accordance
with the marketing authorization issued by the NRA.
...
...
...
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272
Whether
the establishment undertakes contract analysis.
Specify
names of the tests conducted under a contract: ……
273
Whether
the Contract Acceptor has its manufacturing competency assessed and is a
laboratory acknowledged to carry out the contracted operations correctly.
...
...
...
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274
Whether
the contract clearly states the way in which the authorized person releasing
each batch of product for sale exercises his full responsibility.
IX
Complaints
and product recalls
...
...
...
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Product
complaints and returned products
275
Whether
there are SOPs for handling product complaints and returned products.
...
...
...
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276
Whether
persons are designated to be responsible for transferring, considering, assessing
and handling cases of product complaints and returned products.
277
Whether
any complaints on adverse product reactions are received.
Please
specify: ………………………
...
...
...
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278
Whether
quality control and assurance departments are assigned to consider products
returned from the market due to complaints, defects, expiration or other
reasons that may affect product quality.
279
Whether
if the reason for poor quality of a batch is uncovered, whether other
relevant batches are considered.
...
...
...
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280
Whether
products returned from the market and which have left the control of the
manufacturer are destroyed unless without doubt (about origin, labeling,
storage conditions, etc.) their quality is satisfactory.
281
Whether
the receipt and handling are documented.
...
...
...
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Product
recalls
282
...
...
...
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283
A
system is available to ensure that the recall is carried out in a fast and
effective manner.
284
...
...
...
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285
Whether
there is a final record, including a reconciliation between the delivered and
recovered quantities and measures to be taken.
Please
specify: ………………………
...
...
...
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Self-inspection
286
Whether
a self-inspection team is established.
Specify
names and positions of members: ………………
...
...
...
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287
Whether
there are self-inspection programmes and plans and items.
288
Whether
self-inspection items includes:
...
...
...
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a
Quality
management
b
Personnel
...
...
...
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c
Premises
d
Equipment
...
...
...
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dd
Hygiene
and sanitation
e
Documentation
...
...
...
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g
Manufacturing
and in-process controls
h
Quality
control
...
...
...
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i
Contract
manufacture and analysis
k
Complaints
and product recalls
...
...
...
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l
Self-inspection
m
Results
of previous self-inspections and remedial actions taken.
...
...
...
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289
Whether
self-inspection is documented.
Whether
there is a self-inspection report.
290
Whether
self-inspection results are considered to take necessary corrective actions.
Whether
corrective actions are monitored and assessed.
...
...
...
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11.5.
Templates for Manufacturing processes, Batch processing/packaging records and
List of finished product batch records
The
following templates are prepared under the guidance specified in Section 5.22
through Section 5.33 so that health supplement manufacturers can reference to
when establishing manufacturing processes and prepare batch records.
Manufacturers may develop and/or create their own templates but should comply
with GMP and other relevant requirements.
11.5.1.
Template for Manufacturing process
1.
General information:
- Names,
codes, concentration/content and dosage forms of products: …………………
-
Theoretical yields of a standard batch and package details: ………………………
- Number
of procedure/version and date of issue/entry into force: ……………….
...
...
...
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No.
Material
Code
Amount
For smallest unit of finished product
For a batch of finished products (standard batch size)
Amount
Unit
Amount
...
...
...
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1
………..…
…...
………
…...
………
…...
…
……...…(*)
...
...
...
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………
…...
………
…...
Total:
………
…...
...
...
...
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…...
(*) Any
substance that may disappear in the course of processing
3. Specifications
(parameters, limits and reference to test methods):
-
Materials, packaging: ………………………………………………………..……….
-
Bulk/intermediate products (if any): ………………………………...….
-
Finished products: ………………………………………………………………………...
4. List of
main equipment (intended for the process):
No.
Name of equipment
...
...
...
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Note
1
………………………………..
…………….
…………….
…
………………………………..
…………….
…………….
...
...
...
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6. Detail
description of manufacturing steps:
6.1.
Preliminary processing step:
No.
Requirement
1
Define
sufficient/specific requirements/activities that should be executed according
to GMP (Sections 5.22 to 5.33), such as: room/equipment check; order of
operations and respective requirements such as equipment, reference SOPs,
parameters (times, speed), amount of each material, in-process controls,
sampling, testing, acceptance limits; packaging, labeling, quarantine, input
quotas, etc.
…
…………………………………………………………………………………..
6.2.
Processing step: …………………………………………………………….
...
...
...
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6.4.
Primary packaging step: …………………………………………………………….
6.5.
Secondary packaging step: …………………………………………………………….
Prepared by
Checked by
Approved by
(Date, signature and full name)
(Date, signature and full name)
(Date, signature and full name)
...
...
...
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11.5.2.
Batch processing/packaging records
Product
code and number of respective manufacturing process: ……….
BATCH PROCESSING/PACKAGING RECORDS
Batch
number: ……………
Expiry
date:
…….…
Name,
content and dosage form of product: ….….
Batch
size and package details: …………….……..
Page:
…..../….…
...
...
...
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No.
Name of material
Code
Amount required
Actual amount
For smallest unit of finished product
For a batch of finished products (standard batch size)
Amount
Unit
...
...
...
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Number of test report (3) or acceptance report(4)
Amount
Unit
Amount
Unit
...
...
...
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A
a0
a1
o0
a2
o1
…..
…
…
...
...
...
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…
B(1)
b0
b1
p0
b2
p1
…..
…
...
...
...
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…..
…
C(2)
…..
...
...
...
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…
…..
Total:
z1
q0
z2
q1
…..
…
...
...
...
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(1): Any
substance that may disappear in the course of preliminary processing or
processing;
(2):
Residual products from previous batch (if any);
(3): Test
report of the QC Department
(4): Acceptance
report of the QC or QA Department.
(specify date) ……/……/……
Delivered by
...
...
...
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Received by
(Production personnel)
Controlled by
(IPC personnel)
2.
Preliminary processing:
Start at:
….. hour, …../…../…. (specify date)
No.
Requirement
...
...
...
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1
Define
sufficient/specific requirements/activities that should be executed according
to GMP (Sections 5.22 to 5.33), such as: room/production equipment check;
order of operations and respective requirements such as equipment, reference
SOPs, parameters (times, speed), amount of each material, in-process
controls, sampling, testing, acceptance limits; packaging, labeling,
quarantine, input quotas, etc.
Record
the results obtained: amount of materials used, actual parameters, testing results,
actual yield, etc. and other activities, deviations or unusual events, if
any.
…
End at:
….. hour, …../…../…. (specify date)
(specify date)
……/……/……
Performed by
...
...
...
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Controlled by
(Team leader)
3. Processing:
…………………………………………………..
4.
Shaping: ………………………………………………….
5.
First-level packaging (primary packaging): …………………………………………………………..
6.
Second-level packaging (secondary packaging): ………………………………………………………….
7. Batch record
review (control of residual products/scraps, reconciliation between yields,
other activities, incidents, etc.): ………...
...
...
...
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LIST OF FINISHED PRODUCT BATCH RECORDS
Name of
product: ……………………………………………………………………………
Batch
number: ……………………….. Manufacturing date: …………… Expiry date: ………………..
Start at:
...………………… End at:……………….…
This
batch record includes:
□ 1.
Production order and delivery note
□ 2.
Preliminary processing and processing stage
□ 2.1. Weighing
and dispensation of materials
...
...
...
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□ 2.1.2.
Main material test report (photocopy)
□ 2.1.3.
Record of material weighing and dispensation
□ 2.2.
Preliminary processing
□ 2.2.1.
Note indicating status of preliminary processing room and main production
equipment
□ 2.2.2.
Labels of material(s) dispensed for preliminary processing and weighing note,
if available.
□ 2.2.3.
In-process control note
□ 2.2.4.
Record of preliminary processing step
□ 2.3.
Processing
□ 2.3.1.
Note indicating status of processing room(s) and main production equipment
...
...
...
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□ 2.3.3.
Labels of intermediate products awaiting for processing (where possible)
□ 2.3.4.
In-process control note
□ 2.3.5.
Record of processing step
□ 2.3.
Shaping
□ 2.4.1.
Note indicating status of shaping room(s) and main production equipment
□ 2.4.2. Labels
of material(s) dispensed for shaping and weighing note, if available.
□ 2.4.3.
Labels of intermediate products awaiting for shaping (where possible)
□ 2.4.4.
In-process control note
□ 2.4.5.
Record of shaping step
...
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□ 3.1.
Primary packaging
□ 3.1.1.
Note indicating status of primary packaging room(s) and main equipment
□ 3.1.2.
Labels of bulk products awaiting for primary packaging (where possible)
□ 3.1.3.
In-process control note
□ 3.1.4.
Record of primary packaging
□ 3.1.5.
Specimen of primary packaging printed/assigned batch number or expiry date
□ 3.1.6.
Note of dispensation/adjustment/reconciliation
(received/used/rejected/returned) of primary packaging
□ 3.2.
Secondary packaging
□ 3.2.1.
Note indicating status of packaging room and secondary packaging equipment, if
available
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□ 3.2.3.
Record of batch number/expiry date printing and secondary packaging
□ 3.2.4. Specimen
of secondary packaging printed/assigned batch number or expiry date
□ Box
□ Instructions for use
□
Container label (if available)
□ 3.2.5.
Note of dispensation/adjustment/reconciliation (received/used/rejected/returned)
of secondary packaging
□ 4.
Batch record review
□ 4.1.
Reconciliation between yield of each step and yield of the whole manufacturing
process
□ 4.2.
Review of other activities executed, deviations or unusal events (if available)
□ 4.3.
Finished product test report
□ 4.4.
Finished product release order and receipt note.
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