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MINISTRY OF HEALTH
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SOCIALIST REPUBLIC OF VIETNAM
Independence – Freedom – Happiness
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No: 11/2018/TT-BYT
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Hanoi, May 4, 2018
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CIRCULAR
ON DRUG/DRUG INGREDIENT QUALITY
Pursuant to the Law No. 34/2005/QH11 dated June 14, 2005 on
Pharmacy;
Pursuant to the Government’s Decree No. 54/2017/ND-CP on
detailing a number of articles of, and providing measures for implementing, the
Law on Pharmacy dated May 8, 2017;
Pursuant to the Government’s Decree No. 75/2017/ND-CP dated
June 20, 2017 defining Functions, Tasks, Powers and Organizational Structure of
Ministry of Health;
At the quest of the Director General of the Drug
Administration,
The Ministry of Health promulgates the Circular on Drug/Drug
Ingredient Quality.
Chapter I
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Article 1. Scope
This Circular provides for application of quality standards
of drugs (modern drugs, herbal drugs, vaccines and biological) and drug
ingredients (except herbal ones); drug/drug ingredient tests and procedures for
recall and handling of unconformable drugs.
Article 2. Definitions
For the purpose of this Circular, the terms below shall be
construed as follows:
1. Drug/drug ingredient quality standards are
documents regulating technical characteristics of drugs and drug ingredients,
including quality criteria, quality levels, test methods and other
administrative requirements.
2. GLP stands for Good Laboratory Practice.
3. WHO stands for World Health Organization.
4. ICH stands for International Conference on Harmonization
of Technical Requirements for Registration of Pharmaceuticals for Human Use.
Chapter II
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Article 3. General provisions
1. Pharmacy business establishments and drug preparing
facilities shall apply drug/drug ingredient quality standards by way of
pharmacopeia or internal standards for drugs and drug ingredients produced and
prepared by those facilities.
2. Pharmacy business establishments and drug preparing
facilities must carry out evaluations of test methods stated in drug/drug
ingredient quality standards published and applied by the drug manufacturers. Assessment
and evaluation of test methods are carried out in accordance with guidelines
for assessment of analytic processes by ASEAN or ICH, specified in the Circular
on Registration of Drugs and Drug Ingredients promulgated by the Minister of
Health.
3. The Ministry of Health organizes document assessment and
approval of drug/drug ingredient quality standards, in accordance with
regulations on drug/drug ingredient registration, issuing permits for drugs /drug
ingredients which do not have prior registrations for circulation.
Article 4. Application of pharmacopeia
1. Application of Vietnam’s pharmacopeia and reference
pharmacopeias:
a) Pharmacy business establishments and drug preparing
facilities can apply Vietnam’s pharmacopeia or one of the following reference
pharmacopeias: European, British, United States, International, and Japanese;
b) The application of standards of the pharmacopeias
specified in Point a of this Clause must include all regulations on quality
criteria, quality levels and test methods specified in the respective drug/drug
ingredient’s treatise in the chosen pharmacopeia; also including regulations on
quality criteria, quality levels and test methods specified in the appendix of
that pharmacopeia;
c) If the manufacturer announces its application of one of
the pharmacopeias specified in Point a of this Clause, but adopt test methods
different from the ones specified in the drug/drug ingredient’s treatise in the
chosen pharmacopeia, the manufacturer must prove their chosen methods'
equivalence to the pharmacopeia’s methods. The test results from the methods
stated in the pharmacopeia are the basis for evaluation of drug quality;
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2. Application of pharmacopeias other than the ones
specified in Point a of this Clause:
If the pharmacy business establishment or drug preparing
facility decides to apply a pharmacopeia other than ones specified in Point a
of this Clause, the applied quality standards must at least:
a) Meet the requirements of quality criteria and levels specified
in the respective quality criteria’s treatises in Vietnam’s pharmacopeia or one
of the aforementioned reference pharmacopeias;
b) The applied common test methods must be appropriate for
the equivalent common test methods stated in Vietnam’s pharmacopeia or one of
the reference pharmacopeias specified in Point a of this Clause.
Article 5. Application of internal standards
1. The internal drug/drug ingredient standards must conform
to the regulations specified in Point b, Clause 2, Article 102 of the Law on
Pharmacy, as follows:
a) Meet the requirements of quality criteria and levels
specified in the respective treatises in Vietnam’s pharmacopeia and quality
criteria, quality levels and common test methods specified in the appendix of
Vietnam’s pharmacopeia;
b) If Vietnam's pharmacopeia or the reference pharmacopeias
specified in Point a, Clause 1, Article 4 of this Circular do not have any
treatise for the required drug/drug ingredient, the facility shall form the
standard using the scientific research results (also including the product
development research results) or the regulations in other foreign pharmacopeias
as the basis.
2. The internal standards of drugs prepared in medical
facilities are formed and evaluated for appropriateness by the facility, and
promulgated by the facility's head.
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1. When applying for circulation (or circulation extension)
of a drug/drug ingredient: The quality standards of that drug/drug ingredient
must conform to one of the following pharmacopeias at the time of application:
a) The pharmacopeia’s latest edition;
b) The pharmacopeia’s previous editions which did not come
more than two years before the current edition.
2. In the case of drugs or drug ingredients that have
already been allowed for circulation: For a maximum of two years from the
effective date of the pharmacopeia’s latest edition, the applier or manufacturer
have the responsibility to update the standards of drugs/drug ingredients as
regulated by that edition.
3. During drug/drug ingredient circulation, if the applier
or manufacturer finds any factor that severely affect drug safety, quality or
efficacy or is requested by the Ministry of Health (Drug Administration), the manufacturer
must the update the drug/drug ingredient standards’ criteria in order to bring
that factor under control.
Chapter III
DRUG/DRUG INGREDIENT TESTS
Article 7. Drug/drug ingredient tests
1. The test must be carried out in accordance with the
approved and updated drug/drug ingredient quality standards.
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If the drug is prepared in a medical facility, the test is
carried out in accordance with the drug quality standards formed and
promulgated by the facility.
2. The collection of drug/drug ingredient samples for
testing is carried out in accordance with Appendix I and the sample collection
form in Template No. 1 of Appendix III issued together with this Circular.
3. Presenting drug/drug ingredient test/analysis results:
a) The drug/drug ingredient test and analysis results are
shown on the test/analysis report based on Samples No. 2 and No. 3 shown in
Appendix III issued together with this Circular;
b) The testing facility must present the test/analysis
results of the drug sample, which was collected by the quality inspection
authority, in no more than 15 days after receiving the drug sample, in the
following cases:
- There is information on severely adverse effects of the
drug;
- The drug comes from a facility committing serious
violations against good practice;
- Additional samples of the drug are collected in the cases
mentioned in Point b, Clause 1 and Point b, Clause 2 of this Circular's Article
14.
b) The testing facility must present the test/analysis
results of the drug sample in no more than 20 days after receiving it in the
following cases:
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- The drug does not fit any of the cases mentioned in Points
b and d of this Clause.
d) The testing facility must present the test/analysis
results of the drug/drug ingredient sample in no more than 30 days after
receiving it in the following cases:
- The drug/drug ingredient has test methods that require
long testing time;
- The drug/drug ingredient requires re-testing or reevaluation
of results.
- The drug/drug ingredient has dubious contents or quality,
which require test methods other than the ones stated in the registered quality
criteria;
- The drug/drug ingredient requires test methods that the
testing facility is incapable of conducting (e.g. lack of equipment, chemical, reagents,
reference material).
dd) If the deadlines mentioned in Points b, c and d of this
Clause are not met, the testing facility has to explain the reason for lateness
in a document attached to the test/analysis report;
e) In 24 hours from the time the test/analysis report is
issued, the testing facility must send the form to the quality inspection
authority, the facilities producing or importing the drug/drug ingredient being
tested on and the facility where the sample was taken from.
If the drug/drug ingredient sample does not meet the quality
standards, in 24 hours from the time the test/analysis report is issued, the
testing facility must notify the Ministry of Health (Drug Administration) of
that sample in writing with the test/analysis report attached, both physical
and electronic copies (the latter, which is scanned, can be sent to the email
address quanlychatluongthuoc.qld@moh.gov.vn or via messaging to the Drug
Administration's phone number, with both methods of correspondence using the
testing facility's official email address and phone number). A similar
notification must also be sent to the Department of Health whose jurisdiction
is where the tested drug/drug ingredient comes from.
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4. Filing and handling of complaints about test results:
a) If there is disagreement with the sample’s test results,
in five days from the date the test results are received, the pharmacy business
establishment has the right to request the quality inspection authority to
assign another testing facility to carry out drug/drug ingredient quality
tests/analyses;
b) Re-testing of challenged quality criteria is carried out
at the testing facility designated by the Ministry of Health, as specified in
Clause 2, Article 105 of the Law on Pharmacy.
5. Retention of samples:
a) The drug/drug ingredient sample must be retained after
testing and quality conclusion. The retained sample must be sealed up and
preserved as specified in the conditions on the label.
b) Sample retention period:
- In the case of drug/drug ingredient production and importers:
the finished product's sample must be retained for a minimum of 12 months after
product's expiry date; the active ingredient’s sample must be retained for a minimum
of 12 months after the expiry date of the finished product prepared from that
ingredient.
- In the case of drug testing facilities: the sample
retention period is at least 12 months after the drug’s expiry date, or 24
months after the sample collection date for drug samples collected for quality
inspection; or after the date of receipt for additional collected samples
specified in Point b, Clause 1 and Point b, Clause 2, Article 14 of this
Circular.
6. Archiving records and documents:
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b) The records and documents on narcotic, psychiatric,
precursor and radioactive drugs/drug ingredients must be archived for a minimum
of two years from the expiry dates.
c) After the end of their archive periods, the records and
documents shall be handled in accordance with present regulations.
Article 8. Pre-circulation test for drugs specified in
Clause 4, Article 103 of the Law on Pharmacy
1. Drugs that belong to one of the following categories must
undergo testing carried out by a testing facility designated by the Ministry of
Health (Drug Administration) before circulation:
a) The drugs specified in Points a and b, Clause 4, Article
103 of the Law on Pharmacy;
b) Biologicals which are derivatives of human blood and
plasma;
c) Imported drugs specified in the Government’s Decree No.
54/2017/ND-CP on detailing a number of articles of, and providing measures for
implementing, the Law on Pharmacy dated May 8, 2017;
d) Drugs produced by foreign manufacturers on the list of manufacturers
with drugs that do not conform to quality standards, published by the Ministry
of Health (Drug Administration).
2. Regulations on drug quality tests:
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- The samples of the drugs specified in Points a, b, c,
Clause 1 of this Article shall be collected by manufacturers (in case of
domestic drugs) or importers (in case of imported drugs);
- The facilities importing he drugs specified in Point d of
this Article shall request the state’s quality inspection or testing authority
for to collect samples of those drugs.
b) The importer shall send the drug sample alongside a copy
of the producer’s test report to the testing facility specified in Clause 3 of
this Article for drug quality inspection in accordance with the approved drug
quality standards;
c) Facilities producing or importing vaccines, biologicals
which are antisera, derivatives of human blood and plasma mentioned in Points a
and b, Clause 1 of this Article shall send the sample as specified in Articles
10 and 11 of this Circular;
d) The testing facility must present the received sample’s
test results within the time limit specified in Point c, Clause 3, Article 7 of
this Circular.
3. The Ministry of Health (Drug Administration) shall
designate a testing facility which is granted certificates of eligibility for
pharmacy business including drug testing, or testing facilities specified in
Clause 1, Article 35 of the Law of Medicine meeting GLP requirements, to carry
out drug tests specified in Clause 1 of this Article.
If the testing facility does not have sufficient capacity
for carrying out one or multiple test methods, the testing facility must notify
the production/importer and cooperate with the latter in sending samples to
other GLP-compliant testing facilities or laboratories compliant to ISO/IEC
17025 which have capacity for carrying out those test methods.
4. The designated testing facility report testing activities
to the Ministry of Health (Drug Administration) on a monthly basis, following
Template No. 7 of Appendix III issued together with this Circular.
5. The Ministry of Health (Drug Administration) publishes
and updates the list of designated testing facilities mentioned in Clause 3 of
this Article on the Drug Administration’s website.
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a) Pay its expenses for drug quality tests;
b) Provide reference materials (including those of
impurities) to the testing facility if the National Institute of Drug Quality
Control, the Institute of Drug Quality Control Ho Chi Minh City, the National
Institute for Control of Vaccines and Biologicals or other testing facilities
fail to establish;
c) Circulate and distribute the drugs only after their test
results show conformity to quality standards.
7. Tests on vaccines, biologicals which are antisera,
derivatives of human blood and plasma are carried out in accordance with
Articles 10 and 11 of this Circular.
Article 9. The testing periods for facilities on the list of
manufacturers with drugs that do not conform to quality standards and
withdrawal from that list
1. The testing period starts from the first drug batch's
import date after the Ministry of Health (Drug Administration) publishes the list
of manufacturers with drugs that do not conform to quality standards and lasts:
a) 6 months for the manufacturer having one drug batch with third-degree
violation;
b) 12 months for the manufacturer having one drug batch with
second-degree violation or two or more drug batches with third-degree
violations;
c) 24 months for the manufacturer having one drug batch with
first-degree violation or two or more drug batches with second-degree
violations;
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2. A manufacturer will be withdrawn from the list of manufacturers
with drugs that do not conform to quality standards after meeting the following
requirements:
a) The manufacturer completes all drug tests before
circulation within the time limit specified in Clause 1 of this Article;
The drug manufacturer/registrant files reports which follow
Template No. 7 of Appendix III issued together with this Circular, with proof
of test on all imported drug batches carried out during the implementation of
Clause 1 of this Article;
c) The manufacturer has no drug quality violation (including
voluntary drug recall due to quality) during the implementation of Clause 1 of
this Article.
3. On a monthly basis, the Ministry of Health (Drug
Administration) publishes and updates the list of manufacturers with drugs that
do not conform to quality standards, drops the names of facilities complying
with the regulations this Article's Clause 2 from the list based on reports
from testing facilities that participate in testing activities, drug manufacturers
and registrants.
Article 10. Test on vaccines, biologicals which are
antisera, derivatives of human blood and plasma
1. The production/importer must send the samples and
production records of vaccines, biologicals which are antisera, derivatives of
human blood and plasma to the National Institute for Control of Vaccines and
Biologicals for testing and evaluation before circulation. The sample sending
documents are specified in Article 11 of this Circular.
The production/importer must only circulate vaccines,
biologicals which are antisera, derivatives of human blood and plasma after the
National Institute for Control of Vaccines and Biologicals confirms the
vaccine/biological batches' quality, safety and efficacy and issues quality
certificates.
2. Within the time limit specified in Clause 3, Article 7 of
this Circular, from the date all samples and documents specified in Article 11
of this Circular are received, National Institute for Control of Vaccines and
Biologicals shall:
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b) Issue quality certificates which follow Template No. 8 of
Appendix III issued under this Circular, in which the requirements that are met
and which requirements are not, alongside conclusions on the vaccine/biological
batch's quality, safety and efficacy;
c) Notify the Ministry of Health (Drug Administration) of
the test results.
Article 11. Test samples and records for evaluation of
quality, safety and efficacy of vaccines, biologicals which are antisera,
derivatives of human blood and plasma
1. For local vaccines, biologicals which are antisera,
derivatives of human blood and plasma: The manufacturer shall send the
production records and samples from the product batches (either finished
semi-finished products) to the National Institute for Control of Vaccines and
Biologicals, including:
a) The sample sending form;
b) The vaccine/biological samples to be test on (the number of
samples for each kind of vaccine/biological is specified in the Guidelines for
testing finished vaccines, biologicals which are antisera, derivatives of human
blood and plasma);
c) The records summarizing the vaccine/biological batch’s
production and quality tests (copies certified by the manufacturer);
d) The manufacturer’s batch test report.
2. For imported vaccines, biologicals which are antisera,
derivatives of human blood and plasma: The importer shall send the production
records and samples from the product batches to the National Institute for
Control of Vaccines and Biologicals, including:
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b) The vaccine/biological samples to be test on (the number
of samples for each kind of vaccine/biological is specified in the Guidelines
for testing finished vaccines, biologicals which are antisera, derivatives of
human blood and plasma);
c) The records summarizing the imported vaccine/biological
batch’s production and quality tests (copies certified by the manufacturer or
importer)
d) The quality certificate issued by the country of origin’s
authorities for each batch of imported vaccine/biological (copies certified by
the importer);
dd) The table of data on preservation conditions (cold
storage) during the imported batch’s transport (certified by the importer) from
automatic temperature recorders, freeze indicators (if any).
3. The manufacturer and importer must be responsible for
their documents' legality.
Chapter IV
REGULATIONS ON RECALL AND HANDLING OF NONCONFORMABLE
DRUGS
Article 12. Compulsory drug recall procedure
1. Receiving information on unconformable drugs:
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a) Information on drugs that do not guarantee effective
treatment or is unsafe from the drug registration advisory board or
post-vaccination complication handling advisory board;
b) Information on drug quality criteria that are not met
from drug testing facilities;
c) Information on discovered unconformable drugs from the
Drug Administration, Health/Pharmaceutical inspection authority;
d) Unconformable foreign drug notices from manufacturers, pharmaceutical
and drug quality inspection authorities;
dd) Information on unconformable drugs from public security,
customs and market surveillance;
e) Drug information from pharmacy business establishments
requesting voluntary drug recall.
2. Identification of the violation’s seriousness:
a) In 24 hours from the time the information on
unconformable drugs mentioned in Points a, c, d, dd and e, Clause 1 of this
Article, the Ministry of Health (Drug Administration) shall identify the
violation’s seriousness and draw conclusions on drug recall, based on
evaluation of consumer health's risks.
If the drug registration advisory board's opinion is
requested for identification of the violation’s seriousness, as specified in
Section IV, Appendix II issued together with this Circular, the time limit of
identification of violation's seriousness will be 7 days.
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c) For information on unconformable drugs mentioned in Point
b, Clause 1 of this Article, the handling shall be carried out in accordance
with Article 14 of this Circular.
3. Issuance of drug recall decision:
a) In 24 hours from the time the conclusion on drug recall
is drawn, the Ministry of Health (Drug Administration) shall issue the drug
recall decision in accordance with Clause 1, Article 65 of the Law on Pharmacy;
b) The drug recall decision must include the following
information: drug name, circulation registration number or import permit
number, name of active ingredient, concentration, content, form of preparation,
batch number, expiry date, manufacturer, importer, recall level, the facility
responsible for drug recall.
4. Notification of drug recall decision:
a) The drug recall decision of the Ministry of Health (Drug
Administration) is announced by post, fax, email, telephone or the mass media. The
scope of drug recall announcement is specified in Clause 3, Article 63 of the
Law on Pharmacy;
b) Immediately after making the recall decision, the
Ministry of Health (Drug Administration) announces the drug recall decision on
websites of the Ministry of Health and the Drug Administration, and the
Ministry of Health’s national pharmaceutical database;
Departments of Health announce drug recall decisions on
their websites immediately after receiving those decisions.
Domestic drug manufacturers and importers must notify the
information about recalled drugs to drug traders/users which purchased those
drugs.
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5. Recalling drugs:
a) The drug trader/user must discontinue provision and use
of the recalled drugs; place inventory drugs in quarantine; make a list of drug
traders/users and individuals (if any) that purchased those drugs, contact them
and receive the returned drugs; return the drugs to the providers;
b) The manufacturer (of domestic drugs) and importer
cooperate with the import entrustor or distribution hub (of imported drugs) in
recalling unconformable drugs. The recall form follows Template No. 4 of
Appendix III issued together with this Circular.
The drug trader/provider that fails to recall drugs or
receiving returned drugs shall be notified by facilities and individuals
purchasing those drugs to the local Department of Health and face actions.
c) Drug recall has to be completed within one of the time
limits specified in Clause 3, Article 63 of the Law on Pharmacy.
6. Drug recall report, evaluation and additional measures:
a) In one day (for first-degree recalls) or three days (for
second- and third-degree recalls) from the recall’s date of completion, the
facility in charge of recalling must report the results to the Ministry of
Health (Drug Administration) and the local Department of Health in writing. The
report consists of the following documents:
- Summary drug recall report, which follows Template No. 5
of Appendix III issued together with this Circular.
- List of drug traders/users (including those receiving
drugs from the facility in charge of recalling unconformable drugs, or from
distributors) with their addresses, phone numbers, email addresses (if any),
amount of drugs received, amount of drugs recalled;
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- Drug recall self-evaluation form;
- Investigation results, evaluation of causes, evaluation of
risks in the unconformable drug's other batches and/or other drugs coming from
the same production line.
b) The Ministry of Health (Drug Administration) consider the
report mentioned in Point a of this Clause, evaluate it or send it to the
Department of Health for evaluation. If the drug recall is evaluated to be
insufficient and the product can still be circulated and used, posing a risk to
the consumers' health, the Drug Administration cooperates with the Department
of Health and other related authorities in coercive drug recall.
Article 13. Voluntary drug recall procedure
1. The pharmacy business establishment that carries out
voluntary drug recall shall evaluate and identify the seriousness of the drug's
violation and report on the unconformable drug, seriousness of violation,
reason for recall and handling measure proposal to the Ministry of Health (Drug
Administration) in writing, as specified in Clauses 3 and 4, Article 15 of this
Circular.
2. In three days from the date the pharmacy business establishments’
report is received, the Ministry of Health (Drug Administration) consider the
report and identify the seriousness of the drug's violation as specified in
Appendix II issued together with this Circular.
a) If an agreement with the pharmacy business
establishment’s proposal concerning the drug with third-degree violation is
reached, the Ministry of Health (Drug Administration) shall send an document allowing
the facility to voluntarily recall the drug.
b) In the case of drugs with first- or second-degree
violations, the Ministry of Health (Drug Administration) shall follow the drug
recall procedures mentioned in Clauses 3, 4, 5 and 6, Article 12 of this
Circular;
c) If additional information or clarification of information
in the pharmacy business establishment’s report is needed, the Ministry of
Health (Drug Administration) shall request the establishment to provide
additional information and explanations in writing. In five days from the day
the Ministry of Health’s request is received, the establishment must provide
additional information and explanations in writing.
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Article 14. Handling of drugs not meeting quality standards
by place of collection
1. In the case of unconformable drug samples collected from retailers,
level-III and level-IV medical facilities:
a) In 24 hours from the time the testing facility’s
test/analysis report is received, the Department of Health shall seal the
unconformable drug at the sample’s facility of origin.
b) In 48 hours from the time the testing facility’s
test/analysis report is received, the Ministry of Health (Drug Administration)
shall request the responsible drug registrant/manufacturer/importer to:
- Report its drug distribution to the Ministry of Health
(Drug Administration);
- Request the quality inspection authorities to collect
additional samples from domestic drug manufacturers or importers, and from at
least two wholesalers, with one of them already supplied drugs to the facility
where the samples are collected from;
- Send samples to central testing facilities in order to
have the unfulfilled criteria tested.
c) If at least one of the additional sample does not meet
the quality standards, the Ministry of Health (Drug Administration) shall
identify the violation’s seriousness and draw the conclusion on recalling the
unconformable drug as specified in Appendix II issued together with this
Circular, and issue the drug recall decision as specified in Clause 3, Article
12 of this Circular. The recall's scope and time limit is specified in Clause
3, Article 63 of the Law on Pharmacy;
d) If all of the additional samples meet the quality
standards, the Ministry of Health (Drug Administration) shall only carry out
the steps of identifying the violation’s seriousness, drawing the conclusion on
recalling the unconformable drug, issuing the drug recall decision and drug
handling to the drugs of the facility providing the initial samples.
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a) In 24 hours from the time the testing facility’s
test/analysis report is received, the Department of Health shall seal the
unconformable drug at the facility of origin.
b) In 48 hours from the time the testing facility’s
test/analysis report is received, the Ministry of Health (Drug Administration)
shall issue the drug recall decision applying to the province the facility of
origin is based on and traders/users receiving the drug from that facility, as
specified in Clause 3, Article 12 of this Article, and request the responsible
trader/user/importer to:
- Report its drug distribution to the Ministry of Health
(Drug Administration);
- Request the quality inspection authorities to collect at
least two additional samples from other wholesale establishments, with one of
them already supplied drugs to the facility where the samples are collected
from;
- Send samples to central testing facilities in order to
have the unfulfilled criteria tested.
c) If at least one of the additional sample does not meet
the quality standards, the Ministry of Health (Drug Administration) shall identify
the violation’s seriousness and draw the conclusion on recalling the
unconformable drug as specified in Appendix II issued together with this
Circular, and issue the drug recall decision as specified in Clause 3, Article
12 of this Circular. The recall's scope and time limit is specified in Clause
3, Article 63 of the Law on Pharmacy;
d) If all of the additional samples meet the quality
standards, the Ministry of Health (Drug Administration) shall only carry out
the process specified in Point b of this Clause.
3. If the sample is collected from manufacturers, importers
and preservation service providers, or the sample's quality violation is
identified to be caused by the production process, the Ministry of Health (Drug
Administration) shall identify the violation’s seriousness and draw the
conclusion on recalling the unconformable drug as specified in Appendix II
issued together with this Circular, and issue the drug recall decision as
specified in Clause 3, Article 12 of this Circular. The recall's scope and time
limit is specified in Clause 3, Article 63 of the Law on Pharmacy.
Article 15. Handling of recalled drugs
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2. The recalled drug must be destroyed if it has:
First- or second-degree violation;
b) Third-degree violation, considered by the Ministry of
Health (Drug Administration) to be neither rectifiable nor re-exportable, as
specified by Clauses 3 and 4 of this Article;
c) Third-degree violation, considered by the Ministry of
Health (Drug Administration) to be rectifiable or re-exportable, but the
facility fails to rectify or re-export that drug.
3. Procedure for proposing rectification of recalled drugs:
a) The facility that has recalled drugs shall send the
Ministry of Health (Drug Administration) a document stating the rectification
process, drug quality and stability risk assessment, the program for monitoring
and surveillance of the drug’s quality, safety and efficacy during circulation.
b) In 60 days from the date the facility’s rectification
proposal is received, the Ministry of Health (Drug Administration) must
consider the proposal and reply their agreement or disagreement in writing The
reason for disagreement must be specified;
c) If additional information or clarification of the
rectification's information is required, in 60 days from the date the Ministry
of Health’s (Drug Administration) document is received, the facility must
provide documents additional information and explanations. Failure to do so
within the aforementioned time limit will result in invalidation of the
rectification proposal.
4. Procedure for proposing re-export of recalled drugs:
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b) In 15 days from the date the facility’s proposal is
received, the Ministry of Health (Drug Administration) shall reply their
agreement or disagreement on the re-export in writing; the reason for
disagreement must be specified.
5. The rectification and re-export of recalled drug shall
only be carried out after the written agreement of the Ministry of Health (Drug
Administration) is issued.
6. Drug destruction:
a) The head of the facility that has drugs to be destroyed
shall decide to form the drug destruction council. The council shall have at
least three persons, with one representative having professional
responsibility;
b) Drug destruction must be safe for both humans and
animals, does not pollute the environment in accordance with the rules of law
in environmental protection;
c) Drug destruction that requires special control must be
carried out as specified in Article 48 of Decree No. 54/2017/ND-CP;
d) The facility carrying out drug destruction must notify
the Department of Health, and send the Department a drug destruction form that
follows Template No. 6 in Appendix III issued together with this Circular.
7. The recalled drug handling period shall not exceed 12
months from the recall’s date of completion, as specified in Points a, b and c,
Clause 3, Article 63 of the Law on Pharmacy.
Article 16. Responsibilities for drug recall
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a) Comply with the regulations in Clauses 1, 2 and 3,
Article 64 of the Law on Pharmacy;
b) Regularly review and update information on drug recall
from websites of the Ministry of Health, the Drug Administration, and
Departments of Health.
2. Responsibilities of the Drug Administration:
a) Receive information, identify seriousness of drug’s
violations and issue drug recall decisions;
b) Announce drug recall decisions as specified in Point a,
Clause 4, Article 12 of this Circular, publish information about recalled drugs
on websites of the Ministry of Health and the Drug Administration after those
decisions are issued. Cooperate with Vietnam Television and Voice of Vietnam in
announcing recall of drugs with first-degree violations;
c) Consider the evaluation reports and reply to the pharmacy
business establishments’ proposals for voluntary drug recall, rectification or
re-export of recalled drugs;
d) Cooperate with related units (Ministerial Inspector,
Department of Health, health divisions of other agencies) in inspection of
organization and execution of drug recall; take actions against violating
facilities in accordance with the regulations of law;
dd) Produce documents providing detailed guidelines for the
processes of drug recall and handling, evaluation of drug recall in drug
manufacturers and pharmacy business establishments.
3. Responsibilities of Departments of Health:
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b) Organize announcement and dissemination of drug recall
information to local drug manufacturers, pharmacy business establishments and
medical facilities;
c) Cooperate with facilities having drugs with quality
violations in collecting additional drug samples as specified in Point b, Clause
1 or Point b, Clause 2, Article 14 of this Circular, or direct the testing
facilities to do so;
d) Organize surveillance of drug recall in the Departments’
jurisdictions; take actions against and penalize facilities violating drug
recall regulations within their competence;
dd) Participate in or carry out evaluations of pharmacy
business establishments’ drug recall in the Departments’ jurisdictions, under
the Ministry of Health’s (Drug Administration’s) direction. Report any drug
manufacturer, importer, wholesalers which are distribution hubs that fail to,
or insufficiently, recall drugs to the Ministry of Health (Drug Administration)
e) Organize and participate in coercive drug recall.
Chapter V
IMPLEMENTATION PROVISIONS
Article 17. Effect
1. This Circular is in effect from June 20, 2018.
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a) The Minister of Health’s Circular No. 09/2010/TT-BYT
dated April 28, 2010 providing guidance on drug quality management;
b) The Minister of Health’s Circular No. 04/2010/TT-BYT
dated February 12, 2010 providing guidance on sample collection for quality
identification.
Article 18. Implementation
1. The Drug Administration has the responsibility to:
a) Preside over and cooperate with related units in
organizing propagation, dissemination and implementation of this Circular;
b) Preside over and cooperate with the National Institute of
Drug Quality Control, the Institute of Drug Quality Control Ho Chi Minh City,
the National Institute for Control of Vaccines and Biologicals in formulating
plans to collect drug samples for quality inspection and present those plans to
the Ministry of Health for consideration, approval and allocate budget for plan
implementation within the Ministry’s competence.
Collect drug samples for quality inspection and update the
Ministry of Health’s drug quality inspection database with information on
collected drug/drug ingredient samples (including: name of drug/drug
ingredient, concentration, content, type of preparation, batch number, expiry
date, circulation registration number or import permit number, manufacturer,
importer, sample collector) and the drug/drug ingredient’s quality inspection
results;
c) Provide scientific and technical information on ensuring drug/drug
ingredient quality.
Provide the National Institute of Drug Quality Control and
the Institute of Drug Quality Control Ho Chi Minh City with label templates and
the quality standard of the drug/drug ingredient that is issued circulation
registration certificate or import permit (the updated standard if any changes
occur). In the case of vaccines and biological, the label template and quality
standard shall be sent to the National Institute for Control of Vaccines and
Biologicals;
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dd) Preside over or participate in carrying out state inspections,
inspect and take action against violations against the law in drug quality
within the Administration's competence.
2. Departments of Health have the responsibility to:
a) Organize drug quality inspections within their
jurisdictions and take actions against violations in accordance with the law;
b) Formulate plans to collect drug samples for quality
inspection and present those plans to the provincial People’s Committees for consideration,
approval and allocate budget for plan implementation within the Committees’
competence;
c) Update the Ministry of Health’s drug quality inspection
database with information on collected drug/drug ingredient samples (including:
name of drug/drug ingredient, concentration, content, type of preparation,
batch number, expiry date, circulation registration number or import permit
number, manufacturer, importer, sample collector) and the drug/drug
ingredient’s quality inspection results.
3. Responsibilities of the drug testing system:
a) Central drug testing facilities (National Institute of
Drug Quality Control, Institute of Drug Quality Control Ho Chi Minh City,
National Institute for Control of Vaccines and Biologicals):
- Analyze and test samples to identify the quality of
manufactured, circulated and used drugs/drug ingredients; report the test
results to the Ministry of Health (Drug Administration) and the local
Department of Health;
- Research, establish and publish on websites of the
institute and the Drug Administration the list of reference materials
(including those of impurities) for analyses and tests on manufactured,
imported, circulated and used in Vietnam;
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- The National Institute for Control of Vaccines and
Biologicals, on an annual basis, review and evaluate vaccine/biological quality
trends and present the evaluation to the Ministry of Health for consideration,
and formation of guidelines for testing finished vaccines, biologicals which
are antisera, derivatives of human blood and plasma (including reviewing
vaccine/biological batch quality certificate’s test criteria).
Update information about quality certificate issuance for
vaccines, biologicals which are antisera, derivatives of human blood and plasma
on websites of the institute and the Drug Administration.
b) Provincial testing facilities:
- Analyze and test samples to identify the quality of
manufactured, circulated and used drugs/drug ingredients;
- Report the test results to the Department of Health and
the Ministry of Health (Drug Administration).
4. Traders have the responsibility to:
a) Organize researches and carry out implementation of the
regulations of law on drug/drug ingredient quality promulgated by this
Circular;
b) Implement regulations on inspection, control of
drugs/drug ingredients’ source and quality. Carry out quality control in order
to ensure drug/drug ingredient quality throughout the facility's operation;
c) Establish a system of records and documents in order to
monitor circulation of drugs/drug ingredients. Carry out monitoring and
surveillance of the quality of drugs/drug ingredients produced by the facility;
timely discover and handle unconformable drugs, report those drugs to the
pharmaceutical and drug quality inspection authorities.
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a) The National Institute of Drug Quality Control, the
Institute of Drug Quality Control Ho Chi Minh City, the National Institute for
Control of Vaccines and Biologicals, by their functions, tasks and
jurisdictions, to:
- Formulate plans to collect drug samples for testing and
surveillance of drug/drug ingredient quality; reserve, receive and use the
annual budget for sample collection and tests on drug/drug ingredient samples;
- Collect drug/drug ingredient samples in accordance with
the approved plans at establishments doing pharmacy business and using drugs;
- Update the Ministry of Health’s drug quality inspection
database with information on drug/drug ingredient samples collected for quality
inspection and those samples’ test results;
- Report the test results to the Ministry of Health (Drug
Administration) and the local Department of Health if the drug/drug ingredient
samples do not meet the quality standards as specified in Clause 3, Article 7
of this Circular.
- The National Institute of Drug Quality Control shall the
drug quality inspection database for the Ministry of Health;
b) Provincial testing facilities:
- Formulate plans to collect drug samples for testing and
surveillance of drug/drug ingredient quality; reserve, receive and use the
annual budget for sample collection and tests on drug/drug ingredient samples;
- Collect drug/drug ingredient samples for quality
inspection in accordance with the approved plans at establishments doing
pharmacy business and using drugs;
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- Report the test results to the Ministry of Health (Drug
Administration) and the Department of Health if the drug/drug ingredient
samples do not meet the quality standards as specified in Clause 3, Article 7
of this Circular.
Article 19. Implementation responsibilities
The Director General of the Drug Administration, Chief of
the Ministry Office, Chief Ministerial Inspector, heads of units affiliated
with the Ministry of Health, provincial Departments of Health, pharmacy
business establishments, other related authorities, organizations and
individuals have the responsibility to implement this Circular.
If any complication arises during implementation, the
authorities, organizations and individuals are advised to notify the Ministry
of Health (Drug Administration) for consideration and solution.
ON BEHALF OF THE MINISTER
DEPUTY MINISTER
Truong Quoc Cuong
APPENDIX I
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I. Sampling procedures and sampling operations
1. Sampling tools
All sampling tools and implements should be made of inert
and clean materials, which should be suitable for each sample type, ensure no
effect on sample quality, prevent impurities that cause contamination of
samples or cross-contamination and ensure safety of sampler (see Section III)
2. Quantity of sample taken
2.1. The quantity of sample taken for analytical and
retention purposes should be calculated according to inspection requirements,
pharmaceutical product quality standards, applied pharmaceutical starting
materials and testing methods but should be sufficient to allow for at least
three analyses or to perform tests to obtain accurate and reliable results.
2.2. Two samples are usually taken from each consignment
(one for analytical purpose and one for retention purpose). Where necessary,
the number of analytical samples and retention samples may be more than two to
be sufficient for testing and retention at relevant organizations.
3. Sampling operations
3.1. Sampling principles:
- Depending on the inspection purpose and each type of
product, the sampler should decide to adopt an appropriate sampling method.
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- The sampling procedure should be such that non-uniformity
of pharmaceutical products in each sampling unit and entire consignment can be
detected. Signs of non-uniformity include differences in shape, size or colour
of particles in crystalline, granular or powdered solid substances; moist
crusts on hygroscopic substances; deposits of solid pharmaceutical product in
liquid or semi-liquid products; and stratification of liquid products.
- Pooling of the samples from the different portions should
be avoided, because this can mask contamination, low potency or other quality
problems. Separate samples should be formed from these portions and containers.
- For finished drug products, the sampling procedure should
take account of the official and non-official tests required for the individual
dosage form (e.g. tablets or parenteral preparations). Non-official tests
could include testing for adulteration and counterfeiting.
- It is not recommended to mix the pharmaceutical product
removed from a container directly with the one left in that container.
3.2. Sampling procedures
- Carry out physical inspection of the consignment:
segregate containers by each type of product and consignment, segregate
containers that show any signs of deterioration and do not ensure cleanliness
for inspection or sampling. Reject unlabelled sampling units.
- Take sampling units from the consignment of products, open
containers to take original samples and reseal the containers from which the
samples were taken. Ensure that the quantity of materials in the original
samples is sufficient to prepare next samples.
- Gently mix original samples into separate samples of each
sampling unit.
- Gently mix separate samples into a common sample.
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3.3. Analytical samples and retention samples should be
placed in sealed and labeled containers. A sample container should be labeled
with name of the pharmaceutical product, name of the manufacturer, lot number,
expiry date, number of containers from which samples were taken, place of
sampling, number of samples taken (if samples taken are pharmaceutical starting
materials for manufacture of narcotic drugs and psychotropic drugs, precursors used as pharmaceutical
products and starting materials for manufacture of radiopharmaceuticals), date
of sampling and storage conditions in accordance with the sampling record.
3.4. After the sampling is done, analytical samples and
retention samples should be separately sealed to ensure their safety during
transportation. The seal should clearly specify the date of sampling and bear
at least signatures of the sampler and the representative of the establishment
where the sample was taken.
Where necessary, the remainder of the sampling interval
should be also sealed to prevent tampering of pharmaceutical products and
pharmaceutical starting materials.
3.5. Make a sampling record: The sampling record should
contain the batch number, date and place of sampling, storage conditions, notes
on possible abnormalities, any other relevant observations and at least the
name and signature of the sampler and representative of the establishment where
the sample was taken.
In the cases where the quality inspectorate takes samples,
the record is required to bear the signature of the inspectorate's head.
In case the representative of the establishment where the sample
was taken fails to sign the record, the record should bear the signatures of
the sampler and witness.
The record should be made into three copies, which are kept
at the establishment where the sample was taken, testing authority and
pharmaceutical product quality inspecting authority respectively.
4. Sampling of pharmaceutical starting materials
4.1. In case the material is placed in one container only:
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4.2. In case the consignment of material is placed in
multiple containers:
Depending on the sampling purpose, uniformity and quality of
the consignment of material, adopt an appropriate sampling method according to
Section Clause 9 of this Appendix.
5. Sampling of unpackaged semi-finished products
These products include powdered pharmaceutical products,
solutions, syrups, ointments, granules, tablets, injections, etc. that are
transported in large containers to the packaging facility. Samples shall be
taken from each consignment as follows:
1. If the consignment of products is contained in 1 - 2
containers, open the two containers. If the consignment of products is
contained in more than 3 containers, open the three containers. Take at least 3
original samples in different locations of each container.
2. Mix original samples into a common sample, and then form
final samples, including analytical and retention samples.
6. Sampling of packaging materials
Samples of packaging materials shall be taken as prescribed
in Section 1 Clause 9 of this Appendix.
7. Sampling of finished pharmaceutical products
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a) Samples should be taken at random and at different
locations of the consignment.
b) According to the pharmaceutical product quality standard,
the quantity of pharmaceutical product taken should be sufficient to allow for
testing and retention. If information is insufficient for accurate calculation
of the quantity of pharmaceutical product to be taken, consider the minimum
quantity of finished pharmaceutical products provided in Section V of this Appendix.
c) Sampling procedures should be completed according to the
guidelines provided in Section II of this Appendix.
7.2. Take samples to carry out visual inspection upon import
of pharmaceutical products: the quantity of sample taken to carry out visual inspection
is specified in Section IV of this Appendix.
8. Sampling of herbal pharmaceutical starting materials
If herbal medicinal products or partially processed herbal
medicinal products, including animals and plants (dried medicinal plants and
parts thereof) and minerals are regarded as homogeneous, samples thereof shall
be taken as prescribed in Section I Clause 9 “r plan” of this Appendix.
9. Sampling plans for pharmaceutical starting materials and
packaging materials
9.1. Before sampling, the sampler should check the integrity
and deterioration of the container, and uniformity of products in each sampling
unit.
9.2. Sampling should be carried out according to one of the
three sampling plans provided in Table 1 below.
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Value of n, p, r
Values of N
n plan
p plan
r plan
2
up to 3
up to 25
up to 2
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4 - 6
25 - 56
3 - 4
4
7 - 13
57 - 100
5 - 7
5
14 - 20
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8 - 11
6
21 - 30
157 - 225
12 - 16
7
31 - 42
17 - 22
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43 - 56
23 - 28
9
57 - 72
29 - 36
10
73 - 90
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37 - 44
a) The n plan
The “n plan” should be used only when the material to be
sampled is considered uniform and is supplied from a recognized source. Samples
can be withdrawn from any part of the container (usually from the top layer).
The “n plan” is based on the formula n = 1 + 
, where N is the number of sampling
units in the consignment. The value of n is obtained by simple rounding.
Original samples are taken from n sampling units selected at random and these
are subsequently placed in separate sample containers. These original samples
are visually inspected and tested for identity. If the results are concordant,
the original samples are combined into a final, common sample from which an
analytical sample is prepared, the remainder being kept as a retention sample.
b) The p plan
The “p plan” may be used when the material is uniform, is
received from a recognized source and the main purpose is to test for identity.
The p plan is based on the formula p = 0.4, where N is the number of sampling
units. The figures for p are obtained by rounding up to the next highest
integer. Original samples are taken from each of the N sampling units of the
consignment and placed in separate sample containers. These original samples
are visually inspected and tested for identity. If the results are concordant,
p common samples are formed by appropriate pooling of the original samples (if
necessary).
c) The r plan
The “r plan” may be used when the material is suspected to
be non-uniform and/or is received from a source that is not well known, herbal
medicinal products or partially processed herbal medicinal products. This plan
is based on the formula r = 1.5, where N is the number of sampling
units. The figures for r are obtained by rounding up to the next highest
integer.
Original samples are taken from each of the N sampling units
of the consignment and placed in separate sample containers. These original
samples are visually inspected and tested for identity. If the results are
concordant, r samples are randomly selected and individually subjected to
testing. If these results are concordant, the r samples are combined for the
retention sample.
9.3. The abovementioned sampling plans are not recommended
for sampling of starting materials for identification tests. The GMP-WHO rules
shall apply instead.
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1. Bulk liquid products
The steps to be considered when sampling bulk liquid
products are as follows:
- Read and understand the precautions to be observed for the
safe handling of the material.
- Gather
together the required sampling equipment (sampling tube or weighted sampling
can, sample bottles and labels) and check that all the required items are
clean.
- Locate
the batch.
- Examine
the container(s) for signs of contamination of the batch. Record any faults.
- Examine
the labels for obvious differences and signs of changes including obliterations
and mislabelling.
Record any faults.
- Investigate
and clarify the sources of and reasons for any faults before proceeding.
- Choose
a liquid-sampling tube of size and orifice suitable for the viscosity of the
liquid being sampled.
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- Seal
the tube, withdraw it from the bulk liquid, and allow liquid adhering to the
outside of the tube to drain. Transfer all
the contents of the tube to a clean, labelled sample bottle.
- Repeat
steps 8 and 9 until sufficient samples for analytical and retention purposes
have been obtained.
- Seal
the sample bottle.
- Reseal
the container from which the samples were taken and label as “sampled”.
- Clean
and dry the sampling tube, observing the relevant safety precautions.
- Sample
other required containers in the same manner following steps 8–12 above.
- Clean
the sampling tube using the recommended cleaning procedure.
- Deliver
the analytical samples to the laboratory and the reserve samples to the
retention sample store.
Report any aspects of
the sampling that should be brought to the attention of the analyst or the
inspector.
- Check
supplier certificate versus the specifications, if applicable.
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The steps to be considered in sampling a powdered starting
material are as follows:
- Read
and understand the precautions to be observed for the safe handling of the material.
- Gather
together the required sampling equipment (sampling spear, sample bottles and
labels) and check that all items are clean.
- Locate
the consignment and count the number of containers.
- Examine
all the containers for obvious differences and signs of damage. Record any faults.
- Examine
all the labels for obvious differences and signs of changes, including
obliterations and mislabelling. Record any faults.
- Segregate
any damaged containers and those with suspected spoiled contents for separate
examination. These should then be referred or
rejected and dealt with accordingly.
- Segregate
any containers with different batch numbers and treat these separately.
- Number
the remaining containers.
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- Choose
the containers to be sampled in accordance with the requirements of the chosen
plan (by the use of random number tables, by drawing lots or by the use of a
random number generator if applicable).
- Open
the containers one at a time and inspect the contents. Record any differences.
- Choose
a suitable, clean sampling spear and plunge this (gates closed) into the powder
so that the point of the spear reaches the bottom of the container.
- Open
the gates to allow the powder to enter the spear cavities, then reclose them.
- Withdraw
the spear from the container and transfer the spear contents to a labelled sample bottle.
- Repeat
steps 12–14 until sufficient material has been collected for analytical and
retention requirements.
- Seal the sample bottle.
- Reseal
the container from which the samples were withdrawn and label as “sampled”.
- Wipe
clean the sampling spear if required, observing the safety precautions, before
sampling the other chosen containers.
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- Clean
the sampling spear using the recommended cleaning procedure.
- Deliver the analytical samples to the laboratory and the
reserve samples to the retention sample store. Report any aspects of the
sampling that should be brought to the attention of the analyst or the
inspector.
- Check supplier certificate versus the specifications, if
applicable.
3. Packaging materials
The steps to be considered in sampling packaging materials
are as follows:
- Check
the consignment against any associated documentation.
- Check
transit containers for the following and report any deviations as necessary:
+ Correct
identification;
+ integrity
of seal, if appropriate; and
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- Obtain
the required sample from the required number of containers, bearing in mind the
special considerations for sampling packaging materials noted in Section I
Clause 9 of this Appendix.
- Place
the sample units into identified appropriate sample containers.
- Identify
the consignment containers that have been sampled.
- Note
any special situations found during the sampling process (e.g. rogue items or
component damage). Report any such observations as
necessary.
- Remove
all sampled material pallets or containers from the sampling area together with
all documentation.
- Check supplier certificate versus the specifications, if
applicable.
4. Finished products
The following steps should be considered when sampling
finished products:
- Determine
the number of pallets per batch in the consignment.
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+ Check
condition of pallet and packaging for integrity of outer packaging material.
+ Check outside of goods on the pallets for general
cleanliness.
+ Check
that the overall labelling of the pallets matches the packing list.
+ Count,
categorize and record the number of defects.
- Count
the total number of transport packs on the number of pallets present and verify
the total against the packing list.
- From
the number of pallets, work out the number of transport packs to be sampled:
+ Check condition of boxes for integrity of packaging
material.
+ Check
for cleanliness of boxes.
+ Check
the labelling of the boxes for damage.
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+ Check
the labels for spelling mistakes.
+ Check
the labels for manufacturing and expiry dates.
+ Count, categorize and record the number of defects.
- From
the number of boxes selected, work out the number of unit packs to examined
visually:
+ Check
condition of the containers for integrity of packaging material.
+ Check
for cleanliness of containers.
+ Check
condition of containers for shape and colour.
+ Check
the labelling of containers for damage.
+ Check
the containers for overall damage.
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+ Check the labels for manufacturing and expiry dates.
+ Count,
categorize and record the number of defects.
- From
the number of containers selected, determine the number of containers to be
taken for physical and chemical testing and for retention.
- Check
the supplier certificate against the specifications, if applicable.
III. Types of sampling tools
Figure 1. Sampling scoops for solids
Figure 2. Typical dip tube
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Figure 3. Typical sample thieves
(i) The plug thief (Figure 3.i) typically consists of a
hollow tube with an inner rod that has a tip on the end to allow the thief to
enter the powder bed in the closed position. Pointed tips distort the powder
bed less than blunt-tipped probes. Some thieves have a locking device that
allows the sample volume to be set to the required sample weight, thereby
reducing the weight variation in the sample population.
(ii) A chamber thief (Figure 3.ii) generally consists of two
concentric tubes; the inner tube is solid except for the chambers in which the
sample is collected. The outer tube is hollow with openings that can be aligned
with the chambers in the inner tube. A well-designed thief will have a sharp
end to minimize disruption to the powder bed.
Note: When it is inserted into a static powder blend a thief
will distort the bed by carrying pharmaceutical product from the upper layers
of the blend to the lower layers. The magnitude of this distortion can depend
on whether the thief is inserted into the blend with a smooth, jerky or
twisting action. Therefore, staff should be trained in using the appropriate
technique.
The angle at which the thief enters the powder bed can also
influence sampling error. If a thief is inserted into the powder bed
vertically, it can extract samples of different particle size from those that
would be obtained using the same thief inserted at an acute angle. In addition,
the orientation of a chamber thief in relation to the powder bed (i.e. whether
the chamber is at the top, the bottom or in the middle of the thief) may also
influence the sampling error.
Sampling error can also be affected by bed depth, as the
static pressure of the bulk blend forces the material into the sample
chamber(s). This pressure is far greater at the bottom of a large container
than it is in the middle or at the top. It is quite possible that the same thief
could extract samples of different particle size from the top or bottom of a
static powder blend.
Figure 4. Weighted container
For taking samples from large tanks and storage vessels, a
container in a weighted carrier can be used. The container is designed such
that it can be opened at the required depth. Marks on the cord used for
lowering the container can be used to determine when the correct
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Figure 5. Typical sampling spears
A: Closed spear for sampling large grains such as maize
B: Closed spear for sampling small grains such as wheat
C: Open spear
D: Double-tube spear
Sampling spears generally have a maximum external diameter
of about 12 mm, but can be up to 25 mm in diameter and should be 40–45 cm in
length.
IV. Number of sampling units from batches of finished
pharmaceutical products to be taken for visual inspection (ISO 2859-1)
Lot size
Number of sampling units from batches/lots
Number of sampling units from
batches of finished pharmaceutical products to be taken for visual inspection
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2
9 - 15
3
16 - 25
5
26 - 50
8
51 – 90
13
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20
151 - 280
32
281 - 500
50
501 - 1200
80
1201 - 3200
125
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200
10001 - 35000
315
35001 - 150000
500
150001 - 500000
600
Over 500001
1250
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Number of samples of pharmaceutical products and
pharmaceutical starting materials taken for quality inspection (excluding
samples taken for retention purpose):
No.
Dosage form
Type, specifications
Number
1
Tablets, capsules, film coated tablets
1 active ingredient
80 tablets/capsules
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120 tablets/capsules
2
Solutions
≥ 100 ml
20 bottles (vials)
10 - 100 ml
30 bottles (vials)
5ml - 10ml
50 bottles (vials)
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100 bottles (vials)
3
Granules, powders
Packaged in single-dose or multiple-dose
~ 100 gram
Hard pills, soft pills
> 0,5 g/pill
120 pills
0,1 - 0,5 g/pill
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< 0,1 g/pill
500 pills
4
Medicinal liquor
≤ 650 ml
7 bottles
> 650 ml
5 bottles
5
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≥ 250 ml
20 bottles
100 ml - 250 ml
25 bottles
< 100 ml
50 bottles
Syringes
1ml
150 syringes
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120 syringes
Distilled water for injection
2 ml
250 ampoules
5 ml
100 ampoules
10 ml
80 ampoules
6
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≤ 2ml/100mg
100 vials (tubes)
> 2ml/100mg
80 vials (tubes)
7
Topical ointments, creams, gels
≤ 100mg
30 vials (tubes)
> 100mg
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8
Powders for injection
< 100 mg
150 vials
100 - 450 mg
120 vials
> 450 mg
100 vials
9
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1 -
2 ml
30 vials
≥ 5 ml
20 vials
10
Various forms
~100g
11
Herbal medicinal materials
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250 g
Not containing oil
100 g
12
Oil
Various forms
150 ml
13
Vaccines, biologicals
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In accordance with the
manufacturer's regulations
14
Materials
Precious materials
20 g
Antibiotic materials
50 g
Materials for manufacture of narcotic drugs and psychotropic drugs, precursors
10 g
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100 g
Plastic beads
200 g
15
Infusion sets
Various forms
30 sets
16
Hollow glass tubes
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500 tubes
≥ 5 ml
300 tubes
17
Bottles for intravenous fluids
Various forms
10 bottles
APPENDIX II
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I. First-degree violation means a violation where the pharmaceutical product
threatens to cause serious harm to the users’ health or life in one of the
following cases:
1. The pharmaceutical product is counterfeit, illegally
imported and of unknown origins;
2. The pharmaceutical product contains substances banned
from use in manufacture of pharmaceutical products;
3. The finished pharmaceutical product is manufactured from
a material not intended for human use or material not yet granted licenses for use
in manufacture of pharmaceutical products or food intended for human use;
4. The pharmaceutical product is manufactured at a facility
not yet granted the certificate of eligibility for pharmacy business;
5. There is no evidence that the injection or parenteral
pharmaceutical product has undergone quality inspection during the manufacture
process and before release;
6. A foreign competent authority notifies a recall of the
pharmaceutical product;
7. A competent authority concludes that the pharmaceutical
product is not safe;
8. The pharmaceutical product contains wrong active
ingredients;
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10. The parenteral pharmaceutical product fails the
sterility, pyrogen or endotoxin test;
11. The injection is not sterile;
12. The content, route of administration or dose on the
label of the pharmaceutical product that contains a strong active ingredient
and has low safety threshold is incorrect.
II. Second-degree violation means a violation where there is
evidence that the pharmaceutical product does not guarantee effective treatment
or is unsafe for users but does not cause harm to the users’ health or life in
one of the following cases:
1. A competent authority concludes that the pharmaceutical
product does not guarantee effective treatment;
2. The pharmaceutical product is manufactured from materials
that fail to meet specifications;
3. There is no evidence that the pharmaceutical product has
undergone quality inspection during the manufacture process and before release
(except for the case specified in Clause 5 of Section II);
4. The pharmaceutical product is not granted the certificate
of pharmaceutical product registration or the import license;
5. A competent authority concludes that the pharmaceutical
product is granted the certificate of pharmaceutical product registration
according to counterfeit documents;
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7. The pharmaceutical product is manufactured at a
manufacturing facility while it is being suspended or while the certificate of
eligibility for pharmacy business is suspended;
8. The active ingredient content of the pharmaceutical
product deviates by more than 5%;
9. The pharmaceutical product contains wrong active
ingredients (except for the case in which the first-degree violation is
committed);
10. The pharmaceutical product fails to meet specifications
in terms of bacterial contamination (except for the cases specified in Clauses
10 and 11 Section II);
11. The injection or parenteral pharmaceutical product fails
to meet specifications in terms of clarity, impurity, particles visible or
invisible to the naked eye;
12. The tablet fails to meet specifications in terms of
disintegration while it disintegrates in the acidic environment for more than
02 (two) hours (except for enteric-coated tablets);
13. The enteric-coated tablet containing active ingredients
that are unstable or irritate stomach fails to meet specifications in terms of
the disintegration or dissolution in the acidic environment;
14. The liquid injection has a volume smaller than 75% of
that written on the label;
15. The powdered injection has a weight smaller than 75% of
that written on the label;
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17. The pharmaceutical product fails to meet specifications
in terms of relevant impurities;
18. The injection or parenteral pharmaceutical product fails
to meet specifications in terms of pH;
19. The prolonged-release tablet and modified-release tablet
fail to meet specifications in terms of dissolution;
20. The pharmaceutical product fails to meet specifications
in terms of sedimentation of blend and emulsion for injection;
21. The pharmaceutical product is recalled by a foreign
competent authority, except in the case it is urgently recalled, and is found
to be imported into Vietnam through inspection;
22. The pharmaceutical product is incorrect due to mistakes
during manufacture or labeling; the label of the pharmaceutical product
specifies wrong route of administration, dosage, content, concentration of
active ingredients and use (except for the case specified in Section I);
23. The pharmaceutical product is not manufactured and
imported according to the application for pharmaceutical product registration
or import license;
24. The pharmaceutical product contains content or
concentration exceeding the permissible limits.
II. Third-degree violation means violations other than those
specified in Sections I and II that do not affect the treatment ability and
safety of the drug in one of the following cases:
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2. The pharmaceutical product fails to meet specifications
in terms of density;
3. The tablet fails to meet specifications in terms of
weight variation tolerance (average weight of a tablet);
4. The ointment or cream fails to meet specifications in
terms of weight variation tolerance;
5. The powdered injection has a weight greater than 75% of
that written on the label but smaller than the registered limit;
6. The enteric-coated tablet fails to meet specifications in
terms of disintegration but disintegrates for less than 02 (two) hours;
7. The sugar coated tablet and hard pill fail to
disintegrate completely;
8. The tablet fails to meet specifications in terms of
dissolution (except for the case specified in Clause 17 Section II);
9. The tablet fails to meet specifications in terms of
content of active ingredients but the deviation of active ingredient content in
the tablet is less than 5%;
10. The herbal tablet fails to meet specifications in terms
of impurity and humidity;
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12. The liquid pharmaceutical product fails to meet
specifications in terms of pH (except for the case specified in Section II);
13. The oral solution fails to meet specifications in terms
of sedimentation;
14. The oral solution and lotion fail to meet specifications
in terms of volume;
15. The injection fails to meet specifications in terms of
volume but its volume is not smaller than 75% of that written on the label;
16. The injection or parenteral pharmaceutical product fails
to meet specifications in terms of pH;
17. The pharmaceutical product fails to satisfy all labeling
requirements, except for the cases specified in Section I and II;
18. The pharmaceutical product packaging material and method
fail to satisfy storage requirements;
19. The pharmaceutical product fails to satisfy average
weight criterion, the pharmaceutical product is not manufactured according to
the application for pharmaceutical product registration: change of weight of a
tablet, excipient ratio and type of excipients.
IV. Other violations: The Drug Administration of Vietnam shall conclude the
degree of violations after the certification advisory council of the Ministry
of Health comments. Counsel of the council shall be given by assessing effects
of the pharmaceutical product committing violations on users’ health.
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APPENDIX III:
FORMS
(Enclosed with the Circular No. 11/2018/TT-BYT dated May 04, 2018 of the
Minister of Health)
Form No. 01: Sample collection form
Name of the supervisory authority
Name of the establishment
-------
THE SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------
(Place name), date (dd/mm/yyyy) ….
FORM OF SAMPLE COLLECTION FOR
QUALITY VERIFICATION
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Full names, position and workplace of people who took
samples:
1 ................................................................................................................................
2 ................................................................................................................................
3 ................................................................................................................................
Name of the establishment where sample(s) was taken:
………………………………
Classification of the establishment where sample(s) was
taken: ……………………………..
Address:…………………………….. Telephone: ……………………………..
No.
Pharmaceutical product name,
concentration, content, registration number
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Smallest pack
Quantity of sample taken
Name and address of manufacturer
Name of importer (in case of
imported pharmaceutical product), distributor
Status of batch of pharmaceutical
product prior to sampling
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Storage condition upon sampling: ………………….
This form is made into 03 copies: 01 copy is kept at the
establishment where sample(s) was taken, 01 copy is kept at the testing
authority, 01 copy is kept at ……….(authority in charge of quality inspection
and management).
Person(s) taking samples
(signature and
full name)
Representative of the
establishment where sample(s) was taken
(signature and
full name)
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Name of the supervisory authority
Name of the testing authority
-------
THE SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------
TEST REPORT
No.
Sample to be tested:
Manufacturer:
Importer (in case of foreign pharmaceutical product):
Batch number: Date of manufacture: Expiry
date:
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Place where sample was taken (sending sample):
Person taking sample (sending sample):
Testing requirements (specify contents, number and date
of sample collection form or enclosed documents)
Date of receiving sample:
Test registration number:
Person delivering sample: Person
receiving sample:
Standard applied:
Status of sample upon receipt and opening of seal for
testing:
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Quality requirements
Results and conclusions
1.
2.
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3…
Conclusion: (Specify whether the batch meets specifications; in case of
failure to meet, specify reasons thereof).
(Place name), date (dd/mm/yyyy) ….
Head of the testing authority
(signature and seal)
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Name of the supervisory authority
Name of the testing authority
-------
THE SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------
ANALYSIS REPORT
No.
Sample to be analyzed:
Manufacturer:
Importer (in case of foreign pharmaceutical product):
Batch number: Date of manufacture: Expiry
date:
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Place of sending sample:
Person sending sample:
Analysis requirements (specify contents, number and date
of sample collection form or enclosed documents)
Date of receiving sample:
Analysis registration number:
Person delivering sample: Person
receiving sample:
Standard applied:
Status of sample upon receipt and opening of seal for
analysis:
Quality characteristics
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Results
1.
2.
3...
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(Place name), date (dd/mm/yyyy) ….
Head of the testing authority
(signature and seal)
Form No. 04: Pharmaceutical product
recall form
Name of the supervisory authority
Name of the establishment
-------
THE SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------
(Place name), date (dd/mm/yyyy) ….
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PHARMACEUTICAL PRODUCT RECALL FORM
We are: (specify name and position of each member):
1/................................................................................................................................
2/................................................................................................................................
3/ ...............................................................................................................................
from ...........................................................................................................................
were assigned to recall pharmaceutical products that fail to
meet specifications according to the Official Dispatch No. …………...... dated
(date/month/year) .... of
We recalled the following pharmaceutical products at
……………………:
No.
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Unit
Quantity of pharmaceutical
products recalled
Batch number
Manufacturer
Notes
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Representative of the
establishment where pharmaceutical products were recalled
Members
Head of recall department
Form No. 05: Pharmaceutical product
recall report
Name of the supervisory authority
Name of the establishment
-------
THE SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
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PHARMACEUTICAL PRODUCT RECALL REPORT
To:...
Implementing the Official Dispatch No. …………...... dated
(date/month/year) .... of .... on recall of the pharmaceutical product...,
registration number..., batch number..., date of manufacture..., expiry date...
manufactured by... and imported by... (in case of imported pharmaceutical
product),...(Name of the establishment) would like to submit a pharmaceutical
product recall report. To be specific:
1. Information about the batch of recalled pharmaceutical
product:
- Name of the pharmaceutical product, number of registration
certificate or import license, name of active ingredient,
concentration/content, dosage form, batch number, expiry date, manufacturer,
importer;
- Time of release/import;
2. Recall results:
2.1. Result of recall of the pharmaceutical product from
pharmacy business establishments:
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Name of the trader purchasing
pharmaceutical product
Unit
Quantity of pharmaceutical
products purchased
Quantity of pharmaceutical
products sold
Quantity of pharmaceutical
products recalled
Notes
1
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2
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3...
Total
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2.2. Consolidation of recall results
- Quantity of pharmaceutical products manufactured/imported;
- Quantity of pharmaceutical products sold on the market;
- Quantity of pharmaceutical products recalled.
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Form No. 06: Pharmaceutical product
destruction form
Name of the supervisory authority
Name of the establishment
-------
THE SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------
No.
(Place name), date (dd/mm/yyyy) ….
PHARMACEUTICAL PRODUCT DESTRUCTION
FORM
Implementing the Decision No. …….. dated (date/month/year) …
of ……… on destruction of pharmaceutical products that fail to meet
specifications and expire.
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The pharmaceutical product destruction council established
according to the Decision No. …….. dated (date/month/year) … of ……… is composed
of:
1 ................................................................................................................................
2 ................................................................................................................................
3 ................................................................................................................................
...................................................................................................................................
and have witnessed and carry out destruction of the
following pharmaceutical products:
No.
Pharmaceutical product name,
concentration, content
Batch number
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Planned quantity of pharmaceutical
products destroyed
Actual quantity of pharmaceutical
products destroyed
Difference
(*)
Notes
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((*) If there is difference between the actual and planned
quantity of pharmaceutical products destroyed, explanation thereof must be
provided)
Destruction method:
...................................................................................................................................
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
The pharmaceutical product destruction form is sent to .................................................
This form is made into ….. copies, each of which is kept by
a party and ……. copies are sent.
Members destroying pharmaceutical
products
(signature, full name and title)
President of the pharmaceutical
product destruction council
(signature and full name)
Form No. 07: Report on sampling of
pharmaceutical products for quality inspection
Name of the supervisory authority
Name of the establishment
-------
THE SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
(Place name), date (dd/mm/yyyy) ….
REPORT ON SAMPLING OF PHARMACEUTICAL
PRODUCTS FOR QUALITY INSPECTION
To: The Drug Administration of
Vietnam - The Ministry of Health
Name and address of manufacturer
Name of manufacturing country
Name of pharmaceutical product
(dosage form), active ingredients, content
Registration number or import
license number
Batch number, date of manufacture
(if any), expiry date
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Quantity of pharmaceutical products
imported (*)
Name and telephone of the applicant
(*)
Name and telephone of the importer
(*)
Name and telephone of the
establishment entrusted to import
(*)
Name and telephone of Class I
distributor (if any)
(*)
Date of import (*)
Name and telephone of sampling
facility and testing facility
Date of sampling
Date of issuing test report
...
...
...
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
...
...
...
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
...
...
...
Bạn phải
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TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
...
...
...
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
...
...
...
Bạn phải
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TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.
Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
...
...
...
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
...
...
...
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
...
...
...
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
(*) The sampling facility and testing facility are not
required to report these contents.
...,(Place name), date
(dd/mm/yyyy) ….
Head of the establishment
(signature and seal)
Form No. 08: Certificate of
vaccine/biological quality
Name of the supervisory authority
Name of the establishment
-------
THE SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------
CERTIFICATE OF VACCINE/BIOLOGICAL
QUALITY
...
...
...
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Commercial name:
Common name:
Number of Certificate of registration or import license:
Quantity sample of the testing facility:
Batch No. (on the vial/syringe/phial):
Batch No. (on the box):
Date of manufacture:
Expiry date:
Packaging method:
...
...
...
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ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Expiry date:
Manufacturer:
Importer:
Date of manufacture/ import:
Quantity vaccines/biologicals manufactured/imported:
Conclusion:
(Specify whether the batch satisfies specifications approved
by the Ministry of Health or whether the batch satisfies requirements for
document inspection and storage conditions in the cold chain during the import.
In case of failure to satisfy, specify reasons thereof).
...
...
...
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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66