QM CL 01 04 en Quality Manual of QM Division

DRUG ADMINISTRATION OF VIETNAM
QUALITY MANUAL
DRUG QUALITY MANAGEMENT DIVISION
CODE: QM.CL.01.04
Prepared by Checked by Approved by
Hà Hoàng Phương Nguyễn Văn Viên Trương Quốc Cường

Full name
Specialist Head of division Director General
Signature
Code: QM.CL.01.04
QUALITY MANUAL
Date of issue:
OF DRUG QUALITY
MANAGEMENT Rev: 04
DIVISION Total pages: 43

DAV
1. The concerned people shall study and comply with contents stated in this document.
2. Contents stated in this document become effective as directed by Director of Drug
Aministration of Vietnam.
3. Each unit shall be delivered 01 copy (stamped). When units want to receive more
copies, they shall request ISO Secretary to obtain the stamped version. Soft copy is
provided via Local Area Network to share information.
RECIPIENTS (clearly state the recipients and tick X in the next box)
□ DAV management board □ Drug registration dept.
□ ISO committee □ Drug quality management dept.
□ Oficial Administration dept. □ Drug price control dept.
Pharm. Legislation & international Drug information and advertising

□ □ dept.
Integration dept.
□ Planning & financial dept. □ Cosmetic management dept.
□ Drug business management dept. □ Inspection dept.
□ NRA committee □ Training Center
□ Drug and Cosmetic magazine □

Drug Administration of Vietnam QM.CL.01.04
REVISIONS
No. Date Position Revised content

01 23/05/2014 - First revision
02 29/01/2015 Doc. code Change the document code from QT.QLD.44 to
QM.QLD.GMP
Document Update according to PIC/S guideline.
structure
03 05/03/2015 Doc. code From QM.QLD.GMP to QM.CL.01
04 18/05/2015 Section 12 Change the title from Inspection Procedures to GPs
Inspection Policy.
Add contents from SOP QT.CL.05.03 – GMP
Inspection Policy
Section 7 Add descriptions on membership of GPs inspection
team and cooperation of Drug registration division
Section 17 Add contents of cooperation between DAV’s division
Section 12 Combine the content of Section 18 - Issuance,
amendment and revocation of GMP certificates into
Section 12 - GPs Inspection Policy
Section 11 Combine the content of Section 19 - Handling
suspected quality defects and Rapid alert system into
Section 11 – Pharmaceutical Quality Management
Section 7 Move the content of Section 21 - Sub-contracting
and Assessing to Section 7 - Administrative structure
Application date: Issue No.: 04

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TABLE OF CONTENT
1. INTRODUCTION ........................................................................................................................ 4
2. PURPOSE.................................................................................................................................. 5
3. SCOPE...................................................................................................................................... 6
4. DEFINITIONS ............................................................................................................................ 7
5. QUALITY MANAGEMENT SYSTEM ........................................................................................... 8
6. THE ORIGIN OF LAW .............................................................................................................. 11
7. ADMINISTRATIVE STRUCTURE ............................................................................................... 14
8. ORGANIZATION AND MANAGEMENT ...................................................................................... 19
9. DOCUMENTATION AND CHANGE CONTROL ............................................................................ 22
10. RECORDS ............................................................................................................................... 23
11. PHARMACEUTICAL QUALITY MANAGEMENT PROCEDURES ..................................................... 25
12. GPS INSPECTION POLICY ....................................................................................................... 26
13. RESOURCES ........................................................................................................................... 36
14. INTERNAL AUDIT ................................................................................................................... 37
15. QUALITY IMPROVEMENT AND CORRECTIVE/PREVENTIVE ACTION ........................................ 38
16. COMPLAINTS ......................................................................................................................... 39
17. LIAISON BETWEEN RELEVANT PARTIES ................................................................................... 40
18. PUBLICATIONS ....................................................................................................................... 43

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1. INTRODUCTION
2.1. The Drug Quality Management (DQM) Division is a functional division of Drug
Administration of Vietnam (DAV), responsible for GMP, GLP, GSP inspection,
certification and other quality issues relevant to medicines, vaccines and biologicals for
the benefit of the patient and population.
2.2. This manual outlines the scope of activities and rights and responsibilities relevant to
quality policies and the quality system within the DQM Division, including GMP, GLP,
GSP inspection and Pharmaceutical quality management.
2.3. GMP, GLP, GSP inspection, certification and Pharmaceutical quality management
activities in the manual adhere to documented operational procedures and all quality
work procedures developed within the system shall be based on this manual.
2.4. In preparing this text, the following documents were used (or noted):
 PI 002-3 (25 Sept 2007) - PIC/S Recommendations on quality system requirements
for pharmaceutical inspectorates;
 ISO 9001:2008 - Quality Management Systems Requirements.

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2. PURPOSE
2.1. The purpose of conducting the GMP, GLP, GSP compliance inspection and other quality
management activities is to assure the quality, safety and stability of pharmaceutical
manufacture, quality control and storage, therefore to safeguard the health of citizens.
2.2. The purpose of Pharmaceutical (including vaccine and biologicals) quality management
activities is to perform the role of authority management over the quality of
pharmaceutical, therefore assures the quality, safety and stability of pharmaceutical have
been manufactured, imported, exported and distributed in Vietnam's territory.
2.3. The primary purpose of DQM division’s quality system is to ensure that adequate quality
standards are maintained conforms to DAV and global cooperation requirements.
2.4. Currently, DQM division is implementing WHO GMP standard, and in our strategy, we
are intending to apply the international PIC/S GMP standard from 2020. Although DQM
division is not yet the member of PIC/S; however, we comply with the objective of
PIC/S, advance the quality inspection continually, and promote the communication of
the inspection related information with other foreign GMP inspectorate.
2.5. The purpose of adopting a common standard of Quality system requirements for
Pharmaceutical Inspectorates (PI 002-3: 25 Sept 2007) recommended by PIC/S is to
achieve consistency in inspection standards between GMP National Inspectorates and
thus to facilitate mutual recognition of and mutual confidence between those
Inspectorates. This standard should help facilitate the membership of PIC/S.

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3. SCOPE
3.1. This document outlines the quality system of DQM division of DAV, regulating GMP,
GLP, GSP Inspection and other Pharmaceutical quality management activities.
3.2. It is intended to be used as a basis to establish, develop and implement the quality
system into DQM division’s activities. In addition, it provides a strong commitment and
evidence that will generate confidence between inspectorates.

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4. DEFINITIONS
Quality system The sum of all that is necessary to implement an organization's quality
policy and meet quality objectives. It includes organization structure,
responsibilities, procedures, systems, processes and resources. Typically
these features will be addressed in different kinds of documents as the
quality manual and documented procedures, etc.
Quality Selected data intended to be periodically observed to assess trends in
indicators performance.
Pharmaceutical Consist of Chemical medicines, herbal medicine, vaccines and biologicals
GPs GMP, GLP, GSP
DQM division Drug Quality Management division
GPs certification Inspection and certification on GMP for pharmaceutical manufacturers;

on GLP for establisments providing pharmaceutical quality testing
services; on GSP for establisments providing pharmaceutical storage
services.
Inspectorate The National body responsible for co-ordinating and carrying out GMP,
GLP, GSP inspections; authorized for issuing or withdrawing GMP, GLP,
GSP certificates of .
Certificates of Certificate that allow establishments to carry out pharmaceutical business

full satisfaction activities (including manufacture, wholesale, retail sale, import, export,
of drug business storage and quality testing services)
conditions
Pharmaceutical String of characters and numbers, which provides specific identity for a
registration registered pharmaceutical product, allowing it to be distributed on the
number market and valid only in a period of time.

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5. QUALITY MANAGEMENT SYSTEM

5.1. Introduction
DQM division establishs and maintains an effective quality management system for its
activities, including GPs inspection, certification and Pharmaceutical quality authority
management. The establishment, implementation, maintenance and formalization of
this quality management system will help ensure increasing effectiveness and advance
efforts both to gain recognition in the international community of pharmaceutical
inspection work and to share relevant experiences.
5.2. General requirements

5.2.1. The DQM division ensures that the quality management system complies with all
relevant requirements related to system establishment, implementation and
maintenance published under ISO 9001:2008 and Quality system requirements for
Pharmaceutical inspectorates (PI 002-3: 25 Sept 2007) per PIC/S recommendation.
5.2.2. The DQM division also establishes quality policies and objectives as well as the
structure and responsibilities of its process.
5.2.3. The DQM division establishes all relevant written procedures related to the
implementation of its process.
5.2.4. Every aspect of the Quality Management System is subject to supervision,
measurement and analysis in order to achieve planned objectives effectively and ensure
continuous improvement.
5.3. Documentation requirements

5.3.1. DQM division establishes quality policies, sets quality objectives, develop a quality
manual, and provide relevant formalized SOPs as required by the quality system. The
DQM division also ensures that the above are executed effectively and that
improvements to such are made on a regular basis.
5.3.2. DQM division prepares specific quality system documents, which shall include: first
stage documentation (the Quality Manual); second stage documentation (System-level
SOPs); third stage documentation (Division-level SOPs); and fourth stage
documentation (related forms and records) as show in Diagram 1.

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Quality
Manual
System Procedures
(SOPs)
Division Procedures (SOPs)
Records (evidence)
Diagram 1: Structure of documentation
Quality Manual: The quality manual shall specify basic documentation

requirements related to Division’s quality policy, quality
system operations and operational planning. These
documents shall be the primary instrument guiding quality
system operations.
System procedures: SOPs describe the basic requirements necessary to
implement successfully the quality system, provide the
common idea between divisions in DAV.
Division procedures: SOPs describe the operational activities carried out by each
division.
Forms and Records: Blank forms and documentary records resulting from the
implementation of various quality activities.
5.4. Quality Manual

5.4.1. For ensuring the inspection and licensing system conformity to international standard,
and maintaining the quality requirements, DQM division has prepared and maintained
a quality manual covering the elements required by PIC/S and ISO 9001:2008,
including the quality system procedures which define the activities of DQM division
and the commitments for maintaining the quality system.
5.4.2. The Quality Manual and SOPs will be developed and finalized by DQM division and
approved by the Director General of DAV.
5.5. Quality policy

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Quality policies of DQM division conform to the general policies of DAV, with more
details according to its responsibility as follow:
 Enhance the management competence in GPs registration and inspection (including
submitted dossier receipt, evaluation, inspection, approval and certificate issuance),
reinforce people’s belief in the GPs inspection.
 Establish and apply the QMS in accordance with ISO 9001:2008, PIC/S (PI 002-3, 25
Sept 2007) and international harmonizing standards.
 Consider human resource as an essential element, offer supports and opportunities for
training, upgrading and experience gaining in serving GMP inspection practice.
 Respect and equality for all kinds of organization.
5.6. Quality management system planning

5.6.1. DQM division shall establish quality indicators that conform to the quality policy and
which are measurable.
5.6.2. Inspection plan and certification system are enacted and that, within the inspection plan,
inspection frequencies and intervals are clearly specified.
5.6.3. Inspections are implemented to a consistent, high standard, equivalent to WHO’s and
PIC/S’s.
5.6.4. Inspection reports are accurate and findings unambiguous, equivalent to PIC/S format.
5.6.5. Inspection and certification operations are conducted in compliance with quality
system requirements.
5.6.6. Implement management reviews and necessary modifications / preventative measures.
A full review of the quality management system shall be conducted annually and
system modifications made in order to maintain system appropriateness.
5.7. Quality Objects

The quality objectives of this system include:
1. Ensure GMP inspection function conform to PIC/S compliance checklist（PS/W 1/2005
Rev 2, 09/2012）which include 78 indicators;
2. Ensure all other function activities conform to ISO 9001:2008 requirements.
3. Improve on a continuing basis the effectiveness of the quality system;
4. Strengthen technical exchanges with overseas inspectorates and enhance mutual
cooperation;
5. Ensure effective communications within the quality management system.

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6. THE ORIGIN OF LAW

6.1. Authority
6.1.1. Article 6 of Pharmaceutical Law (34/2005/QH11) states that “Ministry of Health shall
be responsible to the Government for the Authority management of pharmaceuticals”.
6.1.2. Article 70 of Law on Products and Good Quality (05/2007/QH12) states that Ministry
of Health is Authorization agency on quality management of foods, medicines,
vaccines, biologicals, cosmetics, pharmaceutical materials, household chemicals,
pesticidals, disinfectants, medical equipments.
6.1.3. Article 48 of Law on Products and Good Quality (05/2007/QH12) states that
“Inspection team is established by Authorization agency base on inspection plan which
is already approved by authorized agency or in case of unexpected inspection request”.
6.1.4. Article 49 and 51 of Law on Products and Good Quality (05/2007/QH12) defines the
Tasks and powers of Quality inspection team and quality inspectors:
 To request production and business organizations or individuals to produce documents
related to products and goods according to examination contents specified in Article 27
and handle violations during the examination according to Articles 30 and 40 of this
Law; when necessary, to request production and business organizations or individuals
to supply copies of documents specified in this Clause;
 To take samples for testing when necessary;
 To seal goods and suspend the sale of unconformable goods on the market in the
process of examination;
 To request organizations or individuals producing and/or trading in goods which fail to
conform to announced applicable standards or relevant technical regulations to take
remedies or repair the goods;
 To propose the Quality inspection agency to handle violations according to their
competence prescribed in this Law;
 To ensure the principles of objectivity, accuracy and non-discrimination while
conducting inspection;
 To keep secret inspection results and information related to inspected production and
business organizations or individuals;
 To report accurately and promptly examination results to the Quality inspection
agency;
 To take responsibility before law for examination results, conclusions and the handling
of violations.
6.1.5. Circular 09/2010/TT-BYT (dated 28 Apr 2010) of Ministry of Health on
Pharmaceutical quality management, Article 24 states that Drug Administration is the
Authorization quality inspection agency for drug; Article 25 defines the scope of
inspection carried out by drug quality inspection agency:
 Quality inspection of medicines in the course of manufacture or preparation;

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 Inspection of the application of good practice principles and standards to medicine

manufacture, testing and storage and the observance of relevant laws;
 Inspection of the registration of medicines, research of medicine stability, research and
development of products, and labeling of medicines under regulations;
 Sampling of medicines and testing of medicine samples according to registered quality
standards or applicable institutional standards (for medicines prepared according to
prescriptions or medicines prepared for use in hospitals) and to other relevant
regulations;
 Quality inspection of medicines exported, imported, circulated or distributed on the
market;
 Inspection of the observance of good practice principles in medicine distribution,
storage and preservation, conditions for medicine quality assurance and relevant
regulations on conditions for medicine storage, transportation, circulation and
distribution. Inspection of the issuance and implementation of regulations on the
inspection and control of medicine origin and quality in the course of warehousing,
storage, transportation and ex-warehousing;
 Inspection of medicine registration numbers or medicine import permits, and the
observance of regulations on medicine labeling and use instructions;
 Inspection of compliance with medicine recall notices of quality inspection agencies
and medicine manufacturers, importers, import entrusters and wholesalers;
 Sampling of medicines for quality analysis and testing and testing of medicine samples
according to medicine quality standards indicated in medicine registration
dossiers/import dossiers of medicines without registration numbers already accepted
by the Ministry of Health.
6.1.6. Decision 3861/QĐ-BYT (dated Dec 03, 2012) of Minister of Health on defining
functions, tasks, powers and organizational structure of Drug Administration of
Vietnam (DAV), including in point 5 and 11, Article 2, states that DAV has the power
to:
 “Provide direction and exercise state management on drug quality across the
country in compliance with the law”;
 “Grant or recall certificate of Good Manufacturing Practice (GMP), Good
Laboratory Practice (GMP), Good Storage Practice (GSP), Good Pharmaceutical
Container Production Practice in compliance with the law”;
 “Issue decisions within competence on termination of circulation, and recall,
disposal of drugs in compliance with the law”; and
 “Take lead or collaborate with Ministry of Health Inspectorate to conduct specific
inspection of pharmacy and cosmetics; inspection of compliance with law
stipulations on pharmacy and cosmetics as required, and provide administrative
handling in the areas under the management of Drug Administration of Viet Nam in
compliance with the law”.
6.2. Technical regulation standards

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6.2.1. Decision 1570/2000/QĐ-BYT on the application of Good Laboratory Practice (GLP)
principles in testing of medicines.
6.2.2. Decision 2701/2003/QĐ-BYT on the application of Good Storage Practice (GSP)
principles to organizations that manufacture, trade in and store medicines.
6.2.3. Decision 3886/2004/QĐ-BYT on the application of the World Health Organization
(WHO)'s Good Manufacturing Practices (GMP) principles and standards at
Vietnam-based medicine-manufacturing organizations.
6.2.4. Decision 47/2007/QĐ-BYT on the application of principles and standards of Good
Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Storage
Practice (GSP) and Good Distribution Practice (GDP) to organizations that
manufacture, test, trade in, distribute, import, export and store vaccines and medical
biologicals.
6.3. GMP enforcement

6.3.1. Article 16 of Pharmaceutical Law (34/2005/QH11) defines the responsibilies of
pharmaceutical manufacturers, including “To comply with provisions on good
practices in manufacture, distribution, storage, quality control of drugs and relevant
provisions on pharmaceutical professions”.
6.3.2. Decree 79/2006/NĐ-CP (dated August 09th 2006) - Detailed regulations for
implementation of some articles of the Pharmaceutical Law, Article 21 defines the
conditions to archive Certificates of satisfaction of drug trading conditions of drug
manufacturer, in which GMP certificate is mandatory; Article 31 states that the
Certificates of satisfaction of drug trading conditions will be withdrawn if conditions
defined in Article 21 are not secured.
6.3.3. Circular 44/2014/TT-BYT on registration of drugs (including vaccines and biologicals
as defined in Article 2 - Interpretation of terms), states in Article 4 and Article 5, the
mandatory requirement of GMP certificate for drug manufacturer (domestic and
foreign); organizations franchising or franchised to manufacture drugs; herbal
medicines, API manufacturers; and vaccines, biologicals manufacturers.
6.4. Mutual Recognition

6.4.1. ASEAN sectoral mutual recognition arrangement for Good Manufacturing Practice
(GMP) inspection of manufacturers of medicinal products has been signed by Vietnam
as a member of ASEAN.
6.4.2. Exemption cases on GMP inspection are defined in Section 12 – GPs Inspection
Policy.

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7. ADMINISTRATIVE STRUCTURE
7.1. Overview of pharmaceutical professions registration
Drug Drug
DQM
business registration
division
division division
Pharma-
ceutical
Manufacturer GMP Product registration
registration number
Certify on
pharma-
Quality testing ceutical
GLP Certificate of full
service
business satisfaction of
conditions pharmaceutical
business
Storage service GSP conditions
Diagram 2: Overview of pharmaceutical professions registration
7.2. Overview of pharmaceutical quality management

1
PROVINCIAL
HEALTH AGENCY DAV
2
NATIONAL LABS
7 6 5
DQM division
MANUFACTURERS
DISTRIBUTORS 4
3
PHARMACEUTICAL MARKET
Diagram 3: Overview of pharmaceutical quality management

: Information collected from sources
: Instruction on developing market surveillance program or specific cases
: Post-marketing sampling and testing
: Pre-marketing sampling and testing
: Analytical report
: Handling decision

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: Supervising or directly handling

: Executing the decision
7.3. Overview of GPs inspection
DRUG ADMINISTRATION 5
OF VIETNAM
1
2 DRUG QUALITY ESTABLISHMENT
MANAGEMENT DIV.
4 GPs INSPECTION TEAM 3
Diagram 4: Overview of GPs Inspection

: Application for GPs certification/re-certification of Establishments,
: Decision of DAV leader to organize GPs inspection team,
: GPs inspection and follow-up activities (CAPA, …),
: Report of GPs inspection and classify of GPs compliance,
: Decision of DAV:
 Issuance of GPs certificate (if passed); or
 Suspension of establishment operation, request of correction and report; or
 Amendment, abridgement of certificating scope of GMP certificate; or
 Revocation of GPs certificate (if still valid).
7.4. GPs inspection team

7.4.1. GMP inspection team
GMP inspection team consists of maximum 6 members, in which:
 From DAV:
o Leader: Leaders of DQM division or Leaders of DAV
o Secretary and 01-02 member(s): staff of DQM division, Drug registration division
and other DAV’s divisions.
o Drug registration division’s staff take part in GMP inspection team in cases of:
 First-time GMP inspection of Vaccine manufacturer
 There are some doubts on registration dossier or product having issues on
quality or safety during circulation.

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 From NICVB (National Institute for Control of Vaccines and Biologicals): 02 members,
in case of GMP inspection for Vaccine / Biological manufacturers.
 From IDQC (NIDQC - National Institute of Drug Quality Control or HCM-IDQC - Ho
Chi Minh City Institute of Drug Quality Control): 01 member as expert, in case of
GMP inspection for Pharmaceutical manufacturers.
 From Provincial health administration: 01 member as observer.
Inspection team
Leader
DAV Secretar
y
01-02 member(s)
NICVB
01-02 member(s)
NIDQC
Provincial health
01 member administration
Diagram 5: GMP Inspection team membership

7.4.2. GLP inspection team
Inspection team
DAV Leader
Secretar
NICVB y
01-02 member(s)
NIDQC
Provincial health
Diagram 6: GLP Inspection team membership

 From DAV:

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o Secretary: staff of DQM division.

 From NICVB (National Institute for Control of Vaccines and Biologicals): 0 members,
in case of GLP inspection for laboratory having tests on vaccines or biologicals.
 From IDQC (NIDQC - National Institute of Drug Quality Control or HCM-IDQC - Ho
Chi Minh City Institute of Drug Quality Control): 01 member as expert, in case of GLP
inspection for Drug laboratory.
7.4.3. GSP inspection team
Inspection team
DAV Leader
Secretar
y
Provincial health
Diagram 7: GSP Inspection team membership

 From DAV:
o Secretary: staff of DQM division.
7.5. Sub-contracting inspectors and specialists

7.5.1. DQM division normally carries out the GPs inspections with cooperation of sub-
-contract personnel but in any case it still remains the primary accountability.
7.5.2. Sub-contracted personnel or experts may be employed as part of an inspection team to
assist or advise in a technical capacity, but that team is normally be led by a GMP lead
inspector.
7.5.3. Sub-contracted personnel must conform to GPs inspection procedure for
sub-contracting inspectors and specialists (QT.CL.19.xx) and having assigned decision
for joining GPs inspection team by their organization.
7.5.4. Sub-contracted personnel must conform to all basic requirements as described in
section 7.6.
7.6. General considerations

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7.6.1. The structure, personnel and operation of the GPs inspection should meet the objective
of the quality management and to ensure that impartiality is safeguarded.
7.6.2. Inspection team members (including the sub-contracting personnel) should be free
from any commercial, financial and other pressures which might affect their judgment
and freedom to act.
7.6.3. DAV ensures that any persons or organizations external to the inspection organization
cannot influence the result of inspections.
7.6.4. The system for obtaining fees is not improperly influence the inspection procedure.
7.6.5. Inspection team members (including the sub-contracting personnel) are responsible to
declare and update their conflict of interest (SOP # QT.CL.08.xx); and conform to
Code of Ethics in GPs inspection (SOP #QT.CL.20.xx)
7.6.6. Processes of GPs Inspection and Issuing manufacturing license are separated into two
independence Divisions responsible (Drug quality management and Drug business
management division, respectively). GMP, GLP, GSP certificates are madatorate
conditions for manufacturers, establishments supplying quality testing service,
pharmaceutical storage service to receive Certificate of full satisfaction of
pharmaceutical business conditions.
7.6.7. DQM division does not provide any advisory service for any organization.
Reference: * xx is revision number of SOP
※ GMP Inspection Policy（QT.CL.05.xx）
※ Qualification of GMP inspectors（QT.CL.16.xx）
※ Training & evaluating of “Good Practices” (GPs) inspectors（QT.CL.15.xx）
※ Preparing, inspecting and certification on “Good Manufacturing Practice” (GMP)
（QT.CL.01.xx）
※ Conflict of interest handling in GMP inspection (QT.CL.08.xx)

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8. ORGANIZATION AND MANAGEMENT

8.1. Organization
8.1.1. The Drug Administration of Vietnam (DAV) is organized into 12 divisions as the chart
below:
Official Administration dept.
Planning & financial dept.
Deputy
Pharm. Legislation & international Integration dept.
Director
Drug registration dept.
Drug business management dept.

Director
Deputy Drug quality management dept.
General of
Director
DAV Drug information and advertising dept.
Cosmetic management dept.
Drug price control dept.

Deputy
Director Inspection dept.
Drug and Cosmetic magazine
Training Center
Diagram 8: Organizational Chart – Drug Administration of Vietnam (DAV)

8.1.2. DQM division having tasks, reponsibilities, authority assigned by General Director of
DAV, including Pharmaceutical quality management and GPs inspection functions. All
staffs of DQM division share responsibility for GPs inspection relevant work.
8.1.3. The Quality manager of DAV assigns a qualified and experienced person as Division
quality officer to carry out the quality assurance function, including implementing and
maintaining the quality system. Division quality officer will received job assignment
and report directly to Quality manager of DAV.
8.2. Responsibilities and authority

8.2.1. Responsibilities and authority of DQM division
Tasks, reponsibilities, authority of DQM division, assigned by Director General of DAV
(385/QĐ-QLD on Dec 02nd 2013):

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 Consult DAV’s leaders on policies and legislation of pharmaceutical quality

management;
 Create, amend, and propose legislation documents on pharmaceutical quality
management, national standards of pharmaceuticals and other relevant legislation
documents, in cooperation of other relevant organizations or Divisions;
 Pharmaceutical quality management regulation activities:
o Consult DAV’s leaders to manage pharmaceutical quality according to current
regulations;
o Create plan and organize inspection on law compliance in pharmaceutical quality
management, in cooperation of other relevant organizations or Divisions;
o Collect, evaluate requests on certification of Good Manufacturing Practice (GMP),
Good Laboratory Practice (GLP), Good Storage Practice (GSP), Good
Manufacturing Practice in Pharmaceutical packaging material, and propose to
DAV’s leaders for issuance, suspension, revoke of these certificates;
o Process works in implementation, applying: Standards of GMP, GLP, GSP, GMP in
pharmaceutical packaging material;
o Consult DAV’s leaders to suspend, recall of quality non-conformity drug and
destroy of falsified, smuggling, unknown, poor quality, expired drug; Collect,
summarize these information in reports and propose solutions;
o Consult DAV’s leaders on quality management for prescription drug in pharmacy of
health care facility.
8.2.2. Responsibilities and authority of the Head of DQM division
 To manage all operation of DQM division;
 To assign tasks, to balance system resources to obtain system quality objectives
effectively;
 To final review procedures before submitting DAV leader for approval;
 To approve proposal of improvement measures, corrective and preventive actions;
 To take part in management review meeting.
8.2.3. Responsibilities and authority of DQM division Quality Officer
 To ensure all procedures are in compliance with established quality policy and
objectives;
 To supervise the implementation of established procedures;
 To collect / summarize quality issue reports, improvement proposals of staff;
 To self-inspection, identify, record non-conformities of quality system; to propose and
supervise implementation of corrective and preventive actions;
 To summarize and evaluate system quality indicators.
8.2.4. Responsibilities and authority of staff

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Each DQM division staff has a job description, in which clearly mention their specific
works and outcomes. These job descriptions are timely updated to adapt any change in
human resourse or works.
8.3. Management commitment

8.3.1. DAV leaders committed to the development, implementation, maintenance, and
improvement of the quality management system that meets TCVN ISO 9001:2008 as
well as regulatory and statutory requirements.
8.3.2. Beside that, DAV leaders, Head of DQM division committed to the development,
implementation, maintenance, and improvement of the quality management system of
DQM division according to PIC/S’s Quality system requirements for Pharmaceutical
inspectorates (PI 002-3 – 25 Sept 2007).
8.3.3. Regard to the quality system, Head of DQM division committed to:
 Set and revise the quality policy and related objectives; oversee the implementation
of the quality policy through its several stages; and rectify quality objectives and the
policy as needed to address practical considerations.
 Execute or propose to DAV managerment board measures to promote the quality
policy and related objectives to ensure staffs with inspection-related responsibilities
fully comprehend the policy and objectives and are thus capable to, respectively,
implement and attain.
 Quality policy is periodically revised annually in the management review meeting in
order that the policy is always kept appropriate.
8.4. Internal Communications

The Head of Division ensures that internal communication channels and protocols,
essential to the quality management system functioning effectively, are in place.
The term internal communications includes presentations, meetings, announcements,
publications, electronic media, and so on.
8.5. Management Review

There is a system for management review annually of the quality system by DAV leaders,
in which evaluating of all process performance; comparing with quality objectives;
appeals, complaints; deficiencies from internal/external audit and follow-up handling
action (CAPA) are considered. Management review results shall incorporate decisions and
measures to improve the effectiveness of the quality management system or its various
procedures / practices.

※ Self inspection and management review procedure（QT.QLD.03.xx）

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9. DOCUMENTATION AND CHANGE CONTROL

9.1. The DAV establishs and maintains a control system for all documents relating to its
activities, including DQM division’s. This document control system will cover relevant
policies, SOPs, guidance and pertinent external documents (e.g., government regulations
and decisions that instruct the inspection activities).
9.2. The document control system ensures that all internal documents are approved by
Director General of DAV prior to being published and that designated staffs possess the
most up-to-date version of relevant documents. Document versions that are obsolete or
outdated are collected and retained on file for a specified period of time.
9.3. The document management system ensures that all document revisions are subjected to
requisite controls and appropriate approval. Revision histories are clearly evident.
9.4. The most accurate, valid and latest versions of documents and data always be used in
order to maintain the integrity of all system activities. The system of documented
procedures established will:
1. Check and approve the relevance of all documents prior to release;
2. Ensure that documents are reviewed, updated and subjected again to the
pre-release approval process on an as-needed basis;
3. Ensure that document revisions and latest versions are properly identified;
4. Ensure that worksites are provided with appropriate documents and document
versions;
5. Ensure documents are easy to read and comprehend;
6. Ensure external documents are properly identified and, after distribution, properly
controlled;
7. Prevent the misuse of obsolete / outdated documents. Obsolete / outdated
documents retained for any reason shall be properly identified.
9.5. SOPs and other relevant documents of DQM division are amended and revised as
needed to assure conformity with relevant regulations and guidelines.
9.6. Quality officer of division is responsible for reviewing all operational SOP to assure
their compliance to quality sustem requirements.
9.7. Document’s revision and updates are informed to all staff in an effective and timely
manner.

※ Procedure for documents control （QT.QLD.01.xx）

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10. RECORDS
10.1. General
10.1.1. The DAV establishs and maintains a records control system. The purpose of this
system is to provide to the quality management system supporting evidence that is
both relevant and useful.
10.1.2. All records and supporting documentation / data have been drafted and formatted to
ensure easy reading and comprehension and be stored properly in a suitable location
that is easily accessible and protects documents from damage, corruption and loss. A
filing system was established for convenient document retrieval. Each record remains
properly stored until its specific expiration date has expired.
10.1.3. An inventory of records is conducted regularly to identify obsolete or outdated
records. Such records are stored and destroyed in accordance with regulations.
10.2. Records related to GPs inspection

10.2.1. Records related to GMP inspection consist of, but not limited to, following types:
 Certificate application dossiers
 Reviewing records of Certificate application dossier
 Decision on GMP Inspection by DAV leaders
 GMP Inspection plans
 List of attendants of inspection
 GMP inspection records
 Manufacturer’s CAPA reports
 Reviewing records of Manufacturer’s CAPA report
 Proposal to DAV leaders for Issuing of GPs certificate
 Decision of DAV leaders on Issuing of GPs certificate
 Decision on Stopping production in GMP non-compliance facility
10.2.2. These above records provide detailed and relevant information on inspection plans
and inspection itineraries, including conducting direction of each inspection, narrative
descriptions of the actual inspection process, follow-up activities, and issues
regarding certification approval.
10.2.3. All records / data resulting from the inspection process are held in strict confidence
unless otherwise required under freedom of information legislation, or unless
required under exchange of information procedures and arrangements between
National Pharmaceutical Inspectorates (e.g. Mutual Recognition Agreement (MRA)
partners).
10.3. Records related to Pharmaceutical quality management

10.3.1. Records related to Pharmaceutical quality management consist of, but not limited to,
following types:

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 Report on quality of medicine, vaccine and biological

 Decision on suspend or recall of medicine, vaccine and biological
 Instruction to developing pharmaceutical market surveillance program
 List of quality violated pharmaceutical, determined during pre- and post-market
surveillance, to be published on DAV website.
10.3.2. All records related to pharmaceutical quality management are transparency and
updated, informed timely to relevant parties.
※ Procedure for records control （QT.QLD.02.xx）

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11. PHARMACEUTICAL QUALITY MANAGEMENT PROCEDURES

11.1. According to the pharmaceutical quality management regulation, all relevant parties,
including manufacturers, importers/exporters, wholesalers, control laboratories, etc.,
have to submit to DAV all information related to drug quality defects as found,
accompany with evidences.
11.2. Information of quality defects may also come from other source like police, customs,
broadcast media, newspaper and end-users. These kinds of information will lead to a
specific investigation.
11.3. The quality defects will be classified based on their severity and follow by appropriate
handling activities including drug recall and penalization.
11.4. DQM division establishs and maintains a system for issuing rapid alert in case of
1-level quality defect.
11.5. DQM division establishs and maintains an updated list of all performed recalls.
※ Handling and recall of drug’s quality defects (QT.CL.10.xx)
※ Handling and recall of vaccine and biological’s quality defects (QT.CL.11.xx)
※ Handling of counterfeit drug (QT.CL.12.xx)

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12. GPS INSPECTION POLICY

12.1. Technical guidances
12.1.1. Updated WHO guidelines:
 TRS 986 (2014) - Annex 2 - WHO GMP for pharmaceutical products - main
principles
 TRS 961 (2011) - Annex 6 - WHO GMP for sterile pharmaceutical products
 TRS 822 (1992) - Annex 1 - GMP for biological products
 TRS 957 (2010) - Annex 3 - WHO GMP for pharmaceutical products containing
hazardous substances
 TRS 957 (2010) - Annex 2 - WHO GMP for active pharmaceutical ingredients
 TRS 937 (2006) - Annex 3 - Supplementary guidelines on GMP for herbal medicines
 TRS 937 (2006) - Annex 4 - Supplementary guidelines on GMP – Validation
 TRS 953 (2009) - Annex 2 - Stability testing of API and finished pharmaceutical
products
 TRS 961 (2011) - Annex 5 - Guidelines on GMP for HVAC systems for non-sterile
pharmaceutical dosage forms
 TRS 970 (2012) - Annex 2 - WHO GMP - Water for pharmaceutical use
12.1.2. Whenever a WHO updated guideline is published, DAV will announce on its website,
along with the guideline’s Vietnamese version and roadmap for application, normally
6 months after the annoucement.
12.1.3. Good laboratory practices (GLP) guideline according to MoH Decision
1570/2000/QĐ-BYT dated 22 May 2000.
12.1.4. Good storage pratices (GSP) guideline according to MoH Decision
2701/2003/QĐ-BYT dated 29 June 2001.
12.2. Scope of inspection

12.2.1. Scope of GMP inspection
 Domestic drug manufacturers:
o Manufacturers producing chemical drugs;
o Manufacturers producing drugs from herbal medicines;
o Manufacturers producing vaccine and biological products;
o Drug packing companies.
 The foreign drug manufacturers which haves medicines registered and marketed in
Vietnam
 The cases of inspection exempt:
o The drug manufacturers in the ASEAN Countries which have been inspected,
evaluated for GMP certification by Drug National authority recognized in -
Mutual Recognition Agreement in GMP Inspection (ASEAN-GMP-MRA)

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(don’t exempt for the products out of agreement scope such as: vaccine and
biological products);
o The manufacturers of the countries of which Drug National authority is member
of PIC/S group, ICH Group;
o The manufacturers have been inspected and certified on GMP by national
authority of specific country according to Circular 44/2014/TT-BYT (England,
France, Japan, USA, Australia, Canada, EMA)
o The medicines which are registered, marketed in Vietnam are evaluated and
prequalified within Prequalification Program by WHO.
12.2.2. Scope of GLP inspection
 Establishments supplying drugs quality testing service
 Establishments supplying vaccine and biologicals quality testing service
12.2.3. Scope of GSP inspection
 Establishments supplying drugs storage service
 Establishments supplying vaccine and biologicals storage service
12.3. Level of GMP inspection
Certification scope Certification scope
Concise
inspection
GMP components
GMP components
Spot
Full
Full inspection inspe
inspection
ction
12.3.1. Full inspection: This GMP inspection is a full inspection of all applicable
components of GMP and certification provision.
12.3.2. Concise inspection: Manufacturers with a consistent record of compliance with GMP
through previous routine inspections are eligible for concise inspection. The focus of
a concise inspection is on a limited number of GMP requirements selected as
indicators of overall GMP performance, plus the identification of any significant
changes that could have been introduced since the last inspection. Collectively, the
information obtained will indicate the overall attitude of the firm towards GMP.
Evidence of unsatisfactory GMP performance observed during a concise inspection
should trigger a more comprehensive inspection.

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12.3.3. Spot inspection: To investigate in some specified incidents e.g. complaints or recalls
related to suspected of the quality defect in products or report of adverse drug
reaction, etc. Such inspection may be focused on one product, a group of related
products, or specific operations such as mixing, sterilization or labelling.
12.4. Classification of GPs inspection

12.4.1. Routine inspection / Certification inspection: Consist of initial inspection and
re-certification inspection
 Initial inspection: This full inspection shall be conducted when the pharmaceutical
manufacturer is newly established or has no regulatory GPs inspection during last 3
years.
 Re-certification inspection: This GPs inspection is carried out in 3-years frequency,
according to the requests for renewal of a GMP certification from manufacturers who
were passed initial inspection. Depend on GPs-compliance history and major changes
of establishments, scope of the inspection may be decided as:
o Full inspection is indicated when the manufacturer:
 has introduced new product lines or new dosage form of products, or has
made significant modifications to manufacturing processes, or has made
changes in key personnel, premises, equipment, etc.;
 has a history of non-compliance with GMP.
o Concise inspection: As described in 12.3.2.
12.4.2. Follow-up inspection: Follow-up inspections are carried out to:
 To evaluate the result of corrective actions of deficiencies which were observed
during the last inspection. They are normally carried out within 6 months after the
initial inspection, depending on the nature of the defects and the work to be
undertaken. They are limited to specific GPs requirements that have not been
observed or that have been inadequately implemented.
 To monitor the GPs compliane of establishmentbase on its deficiencies in the last
inspection.
12.4.3. Special inspection: Special inspection may be applied in some case as below:
 Spot inspection: As described in 12.3.3;
 To collect specific information in order to perpare a technical guideline or regulation;
 To assess the performance of GMP inspectorate of DAV, supervised by international
organizations (WHO, PIC/S, ASEAN).
12.5. Announcement of inspection

12.5.1. Announced inspections cover Routine inspection and Follow-up inspection.
12.5.2. Unannounced inspections are necessary for spot inspections.

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12.6. GPs inspection procedures

12.6.1. DQM division formalized documentation related to inspection SOPs and resources in
order to ensure that all inspection procedures and activities comply with national
regulations and established inspection plans.
12.6.2. Inspection plan are developed base on product/service characteristics, size of
establishment, inspection resource (time and personnel) and risk analysis.
12.6.3. Detailed SOPs and other documents related to inspection procedures and
post-inspection follow-up measures are available to all inspection team in both
printed and electronic versions.
12.6.4. Qualified inspectors shall implement inspection SOPs, if any deviation may occure,
instructions should be consulted from the inspection team leader.
12.6.5. Observations made and numerical data collected during the course of inspection work
are recorded in a timely manner in order to prevent loss.
12.6.6. Inspector findings are agreed between inspection team, then announced to
establishment in final meeting and published in inspection report.
12.6.7. Inspection report is drafted by inspection team secretary, reviewed by inspection team
leader and head or deputy head of DQM division (whoever not take part in inspection
team) before finally approved by inspection team leader, within the mandated time.
12.6.8. 01 copy of inspection report will be sent to establishment and form a basis to develop
its corrective, preventive action plan.
12.6.9. Format of GMP inspection reports are accordance with the requirement defined in
SOP for preparing, inspecting “Good Manufacturing Practice” (GMP) (QT.CL.01.xx)
and conform to PIC/S giudeline.
12.7. Classification of GMP deficiencies

12.7.1. Critical: A deficiency which has produced, or leads to a significant risk of producing
either a product which is harmful to the human; or any observation that involves
fraud, misrepresentation or falsification of products or data.
In case of critical deficiency which pose a risk that may affect to user’s life and health,
handling procedure is described in Handling of serious violation recognized during
manufacturer inspection (SOP #QT.CL.07.xx)
12.7.2. Major: A non-critical deficiency: which has produced or may produce a product:
 which does not comply with registration dossier; or
 which indicates a major deviation from GMP; or
 which indicates a major deviation from the terms of the manufacturing
authorisation; or
 which indicates a failure to carry out satisfactory procedures for release of batches;
or
 a failure of the authorised person to fulfil his/her required duties; or

Page 29 of 43
 a combination of several "other'' deficiencies, none of which on their own may be

major, but which may together represent a major deficiency and should be
explained and reported as such.
12.7.3. Minor / Other: A deficiency which cannot be classified as either critical or major, but
which indicates a departure from good manufacturing practice. A deficiency may be
“other” either because it is judged as minor, or because there is insufficient
information to classify it as major or critical.
12.8. Classification of GLP deficiencies

12.8.1. Critical: A deficiency which has produced, or leads to a significant risk of testing
fraud, misrepresentation or falsification of result or analytical data.
12.8.2. Major: A non-critical deficiency: which has produced or may leads to:
 Systematically violation of conformation to Standard Operating Procedures; or
 Applying of non-original, non-validated analytical methods; or
 Do not maintain testing, analytical record; having no procedure to manage
analytical data, result; or
 Laboratory conditions fails to meet the analytical methods requirements; or
 Do not retain samples; having no procedure to manage and retain samples; or
 Quality officer, analyst do not fulfil required competence, required professional
training; or
 A failure of the authorised person to fulfil his/her required duties; or
 A combination of several "other'' deficiencies, none of which on their own may be
which indicates a departure from good laboratory practice. A deficiency may be
“other” either because it is judged as minor, or because there is insufficient
information to classify it as major or critical.
12.9. Classification of GSP deficiencies

12.9.1. Critical: A deficiency which has produced, or leads to a significant risk of storage
fraud, misrepresentation or falsification of information or data.
12.9.2. Major: A non-critical deficiency: which has produced or may leads to:
 A major deviation from GSP; or
 A major deviation from the terms of the storage conditions; or
 Do not conform to control procedures of quarantined, quality violated goods; or
 A failure of the authorised person to fulfil his/her required duties; or

Page 30 of 43
 A combination of several "other'' deficiencies, none of which on their own may be

which indicates a departure from good storage practice. A deficiency may be “other”
either because it is judged as minor, or because there is insufficient information to
classify it as major or critical.
12.10. Categorise GPs compliance level of establishment

According to the classified deficiencies stated in inspection report, manufacturer
should be ranked on GMP compliance as follow:
A – Good GPs compliance: Establishment has no critical or major deficiency.
B – Sastified GPs compliance: Establishment has no critical deficiency and 1 - 6
major deficiencies.
C – Basic GPs compliance: Establishment has no critical deficiency and 7-14 major
deficiencies.
D – GPs non-compliance: Establishment has 1 or more critical deficiencies and/or
more than 14 major deficiencies.
12.11. Handling of inspection result

12.11.1. In certification inspection, base on GPs compliance level of establishment, leader of
inspection team should:
A – Good GPs compliance: Propose to DAV leader to issue GPs certificate.
B – Sastified GPs compliance: Propose to DAV leader to issue GPs certificate, but
establishment must submit CAPA plan within 2 weeks from the day of receiving
inspection report.
C – Basic GPs compliance: Establishment must submit CAPA report, including

evidences, within 2 months from the day of receiving inspection report. After
assessing the CAPA report, if number of major deficiencies becomes less than 7
and CAPA plan is realizable, proposal for issuing GPs certificate will be made; if
not, establishment must apply again for GPs certification. Establishment has
maximum 2 times for submitting CAPA report, each period for correcting and
preparing CAPA report is 2 months (See section 12.13).
D – GPs non-compliance: Suspend establishment’s activities, public announce that

the current GPs certificate is no longer valid. Establishment must correct its
deficiencies and apply again for GPs certification.

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12.11.2. In GPs compliance follow-up inspection, base on GPs compliance level of
establishment, leader of inspection team should:
A, B – Good GPs compliance, Sastified GPs compliance: GPs certificate still valid.
C – Basic GPs compliance: Establishment must submit CAPA report, including

evidences, within 2 months from the day of receiving inspection report. After
assessing the CAPA report, if number of major deficiencies becomes less than 7
and CAPA plan is realizable, GPs certificate still valid; if not, GPs certificate will
be revoked, establishment must apply again for GPs certification. Establishment
has maximum 2 times for submitting CAPA report, each period for correcting
and preparing CAPA report is 2 months (See section 12.13).
D – GPs non-compliance: Suspend establishment’s activities, public announce that

the current GPs certificate is no longer valid. Establishment must correct its
deficiencies and apply again for GPs certification.
12.11.3. In spot inspection, base on establishment determined violation level, leader of
inspection team should propose handling measures.
12.11.4. Final decision is made by DAV leaders, base on the proposal from Head of DQM
division.
12.11.5. In case the non-compliance only affect to parts of certification scope, DAV may
consider to amend, concise the scope of certification in GPs certificate.
12.11.6. In some exceptional circumstances below, DQM division may propose to DAV/MoH
leaders in considering risk-benefit balance to decide if a GMP non-compliance
manufacturer may continue producing one or a few determined products in a
determined period of time:
 Supplying medicines, vaccines for emergency demand of epidemic diseases,
overcome consequences of natural disasters, catastrophes.
 Supplying source of alternative product is unavailable, limited or unreasonable.
 Having effective measures to enforce supervising, monitoring in order to assure
or minimize the risk of quality and promptly action plan in case of adverse
events.
12.12. Inspection interval

12.12.1. Interval of certification inspection: 3 years, in considering the application dossier for
re-certification of establishment.
12.12.2. Interval of follow-up inspection: The inspection interval is defined through a risk
based assessment considering the complexity of establishment, the severity of
manufacturing product and GPs-compliance history of establishment. The interval
may be from 1 to 3 years. The risk assessment procedure is described in SOP
#QT.CL.01.xx.

Page 32 of 43

Page 33 of 43
12.13. Time frame of GPs inspection
Application
Supplement Review
request T1 ≤ 5
T2 ≤ 30 Preparation
Supplement
Review T3 ≤ 5 T5 ≤ 60
Inspection
Announcement planing
T4 ≤ 20
Certificate exp. date
Inspection
decision
GMP inspection GMP inspection
Inspection report
T6 ≤ 30
Send report completion
CAPA report
Submit CAPA
T7 ≤ 60 preparation report
Supplement
CAPA report
request review T8 ≤ 10
CAPA 2nd report

T9 ≤ 60 preparation Submit T12 ≤ 180
CAPA 2nd report

Announcement review T10 ≤ 10
Follow-up Follow-up
inspection inspection
Evaluate and
Conclusion conclusion T11 ≤ 5
* Time unit = day

(QT.CL.01.xx)

Page 34 of 43
※ Preparing, inspecting and certification on “Good Laboratory Practice” (GLP)

(QT.CL.02.xx)
※ Preparing, inspecting and certification on “Good Storage Practice” (GSP) (QT.CL.03.xx)
※ Handling of serious violation recognized during manufacturer inspection (QT.CL.07.xx)

Page 35 of 43
13. RESOURCES
13.1. DAV leaders maintains at all levels resources appropriate to achieve set objectives in
an effective manner.
13.2. Head of DQM division ensures that each staff is fully enabled to perform required
tasks and receives relevant training. Such trainings are standardized in documentation
and its effectiveness evaluated.
13.3. Inspectors shall hold appropriate qualifications, experience, relevant professional
knowledge and skills and shall receive appropriate training in order to ensure their
ability to:
1) make professional and correct judgments during the course of inspection work;
2) assess facility compliance with GMP-related rules and regulations; and
3) conduct risk assessments properly.
13.4. Inspectors shall maintain an appropriate level of familiarity with current technology
(e.g., computer systems and information technology) and foreign language (English).
13.5. With the ultimate objective of raising the effectiveness and quality of inspections,
DQM division establishs SOPs to assess inspectors’ technical skills, qualifications,
training and job performance in order to confirm that inspectors meet system
expectations in each category and are able to adhere to all relevant SOPs in the
performance of their inspection duties.
13.6. DQM division establishs a system of management and professional training regimen
specifically for newly hired inspectors. Training standards and requirements for each
inspector will be reviewed and evaluated on a regular basis, with the training records of
each inspector retained on file.

※ Qualification of GMP inspectors（QT.CL.16.xx）
※ Training & evaluating of “Good Practices” (GPs) inspectors（QT.CL.15.xx）
(QT.CL.01.xx)
※ Preparing, inspecting and certification on “Good Laboratory Practice” (GLP)
(QT.CL.02.xx)
※ Preparing, inspecting and certification on “Good Storage Practice” (GSP)
(QT.CL.03.xx)

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14. INTERNAL AUDIT

14.1. DQM division conducts regular, documented internal audits to comply with quality
system requirements as part of internal audit program by ISO committee of DAV. The
results and resultant corrective action are subject to periodically review in order to
ensure effective implementation and maintenance of said results and action within the
quality management system.
14.2. The internal audit process clearly define audit procedures, rules, scope, frequency,
methodology and audit staff qualifications in order to ensure process objectivity and
impartiality.
14.3. Internal audit results are maintained in the files and in accordance with records
management principles for a specified period of time.

※ Self inspection and management review procedure（QT.QLD.03.xx）

Page 37 of 43
15. QUALITY IMPROVEMENT AND CORRECTIVE/PREVENTIVE

ACTION
15.1. Quality improvement
15.1.1. DQM division establishs and maintains quality indicators related to its activities that
conform to the quality policy and which are measurable.
15.1.2. Quality indicators are reviewed during the management review operation.
15.2. Quality Indicators

The quality indicators indicate level of completeness of quality objects and performance of
system, include:
1. Percentage of fulfilled indicators according to PIC/S checklist on GMP inspection
function;
2. Percentage of GMP inspections carried out according to annual plan, before the last
certificate expired;
3. Average processing time from the end of inspection to the date of issuing new
certificate;
4. Quantity of GMP inspectors, who received advance training for working profestional.
15.3. Corrective and Preventive Action

15.3.1. The DAV establishs and maintains SOPs for the investigation of non-conforming
elements of internal / external audit results. These procedures include the
confirmation and implementation of corrective action as well as incorporate
investigations conducted in response to complaints.
15.3.2. The system includes descriptions of the steps to be taken in assessing the need for
quality improvement and preventive actions.
15.3.3. Corrective and preventive action is formalized, with records maintained for a period
of time specified by regulations.
※ Corrective and Preventive Action (QT.QLD.04.xx)

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16. COMPLAINTS
16.1. Complaint procedure of extablishment on Pharmaceutical quality management and
GPs inspection activities is defined in MoH decision 44/2005/QĐ-BYT dated 20 Dec
2005 on Complaint handling in medical field.
16.2. DQM division establishs and maintains a SOP for handling of complaints, related to
activities or personnel in Pharmaceutical quality management and GPs inspection
activities. The SOP described the method by which complaints are reported and require
follow-up investigation(s) to ensure that resultant corrective actions were
implemented.
16.3. All records of complaints and resultant revisions are retained for an amount of time
mandated by regulations.
※ Complaint handling related to GMP inspection (QT.CL.09.xx)
※ MoH decision 44/2005/QĐ-BYT dated 20 Dec 2005 on Complaint handling in medical
field

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17. LIAISON BETWEEN RELEVANT PARTIES

17.1. Drug Quality Management division - Drug Administration of Vietnam
17.1.1. Receiving, reviewing GPs certification or re-certification dossier; conducting GPs
inspection; evaluating Corrective & Preventive Action (CAPA) plan; issuing,
amendment or revocation of GPs certificate;
17.1.2. Dealing with report issues from NICVB, NIDQC, HCM-IDQC, GDPM, ADR/AEFI
monitoring agents; analyzing the risk assessment for the quality defects and arranging
the irregular inspection when necessary;
17.1.3. Publish information of GPs compliance on DAV website (http://www.dav.gov.vn);
17.1.4. Publish information of pharmaceutical quality violation on DAV website
(http://www.dav.gov.vn);
17.1.5. Sharing information with NICVB, NIDQC, HCM-IDQC, GDPM, ADR/AEFI
monitoring agents, Drug registration division, Drug & Cosmetic inspection division,
Drug business management division (DAV) on GMP inspection result with
compliance level of C, D or GMP certificate amendment or revocation;
17.1.6. Handling appeals or complaints related to DQM division activities.
17.2. Drug registration division - Drug Administration of Vietnam

17.2.1. Provide information to DQM division on new application of vaccine registration
dossier; or concession manufacturing.
17.2.2. Sharing information with DQM division related to registration dossier and change
submission dossier of manufacturers;
17.2.3. Cooperate, join GMP inspection team upon requested.
17.3. Drug & Cosmetic inspection division - Drug Administration of

Vietnam
17.3.1. Receive information of violation from DQM division to follow-up with finance
penalty per regulation.
17.3.2. Sharing information of violation handling activities with DQM division related to
manufacturers, establishment supplying pharmaceutical quality testing and storage
service.
17.4. National Institute for Control of Vaccines and Biologicals – NICVB

17.4.1. Cooperating with DQM division (DAV) in GMP inspecting of vaccine or biological
manufacturer;
17.4.2. Sharing information with DQM division (DAV) in case of lot release failures or
quality defects;

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17.4.3. Submitting to DQM division (DAV) annual quality control report of vaccine or
biological products.
17.5. National Institute of Drug Quality Control (NIDQC) and Hồ Chí

Minh city’s Institute of Drug Quality Control (HCM-IDQC)
17.5.1. Cooperating with DAV in GMP inspecting of pharmaceutical manufacturer;
17.5.2. Quality testing on drug sample;
17.5.3. Sharing information with DQM division (DAV) in case of quality defects, accompany
with analytical reports; submitting to DAV summary report of medicines quality
control conducted by NIDQC and provincial laboratories.
17.5.4. Annually, DQM division (DAV) announces a list of manufacturers which were found
to have GMP problems, as the basis for NIDQC and provincial laboratories to
develop market surveillance program.
17.6. Provincial health administrations

17.6.1. Provincial health administrations are responsible to take all appropriate legal
measures and to notify central government health authorities when legal infractions
are identified during the market surveillance of pharmaceutical products.
17.6.2. Representative of Provincial health administration join GPs Inspection team as a
observer, in order to be aware of manufacturer’s operation and to improve knowledge
aand skills in pharmaceutical management of the province.
17.7. General Department of Preventive Medicine and ADR/AEFI

monitoring agents
GDPM and ADR/AEFI monitoring agents is in charge of reporting DAV any
ADR/AEFI issue of vaccines, biologicals and drugs.
17.8. Police
In cases of serious violation of laws, DAV should provide all information and
evidences to police department for prosecution.
17.9. Establishment
17.9.1. Establishment has to submit the dossier for GPs certification or re-certification to
DAV and pay a fee according to the DAV regulation.
17.9.2. In case of GPs re-certification, the dossier must be submitted at least 02 months
before the expiration of the current valid GMP certificate. During the intermediate
stage after submiting re-certification dossier and waiting for GPs inspection,
operations at establishment’s inspection site could be continued as normal.

Page 41 of 43
17.9.3. Establishment has to inform and seek for approval of DAV before making any change
that may affect its product/service quality.
※ Vaccine Quality Control manual (QM.NRA.RS.xx)
※ Handling and sharing of information related to vaccine defects and GMP non-compliance
(QT.CL.18.xx)

Page 42 of 43
18. PUBLICATIONS
DQM division maintains publishing an updated list of following contents on DAV
website:
 List of GPs certified establishments included with their certificate’s status of valid
or invalid.
 List of recalled substandard drugs, vaccines and biologicals
 List of foreign manufacturers having substandard products, 100% of their imported
lots must be tested before circulating.
Reference:
※ DAV website: http://www.dav.gov.vn

Page 43 of 43

QM CL 01 04 en Quality Manual of QM Division

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DRUG ADMINISTRATION OF VIETNAM

Prepared by Checked by Approved by

Hà Hoàng Phương Nguyễn Văn Viên Trương Quốc Cường

DIVISION Total pages: 43

□ DAV management board □ Drug registration dept.

□ ISO committee □ Drug quality management dept.

□ Oficial Administration dept. □ Drug price control dept.

Pharm. Legislation & international Drug information and advertising

□ Planning & financial dept. □ Cosmetic management dept.

□ Drug business management dept. □ Inspection dept.

□ NRA committee □ Training Center

□ Drug and Cosmetic magazine □

No. Date Position Revised content

Application date: Issue No.: 04

Application date: Issue No.: 04

Application date: Issue No.: 04

Application date: Issue No.: 04

Application date: Issue No.: 04

Pharmaceutical Consist of Chemical medicines, herbal medicine, vaccines and biologicals

GPs GMP, GLP, GSP

DQM division Drug Quality Management division

GPs certification Inspection and certification on GMP for pharmaceutical manufacturers;

Certificates of Certificate that allow establishments to carry out pharmaceutical business

Application date: Issue No.: 04

5. QUALITY MANAGEMENT SYSTEM

5.2. General requirements

5.3. Documentation requirements

Application date: Issue No.: 04

Division Procedures (SOPs)

Diagram 1: Structure of documentation

Quality Manual: The quality manual shall specify basic documentation

5.4. Quality Manual

5.5. Quality policy

Application date: Issue No.: 04

5.6. Quality management system planning

5.7. Quality Objects

Application date: Issue No.: 04

6. THE ORIGIN OF LAW

Application date: Issue No.: 04

 Inspection of the application of good practice principles and standards to medicine

6.2. Technical regulation standards

Application date: Issue No.: 04

6.3. GMP enforcement

6.4. Mutual Recognition

Application date: Issue No.: 04

Diagram 2: Overview of pharmaceutical professions registration

7.2. Overview of pharmaceutical quality management

Diagram 3: Overview of pharmaceutical quality management

Application date: Issue No.: 04

: Supervising or directly handling

4 GPs INSPECTION TEAM 3

Diagram 4: Overview of GPs Inspection

7.4. GPs inspection team

Application date: Issue No.: 04

Diagram 5: GMP Inspection team membership

Diagram 6: GLP Inspection team membership

Application date: Issue No.: 04

o Secretary: staff of DQM division.

Diagram 7: GSP Inspection team membership

7.5. Sub-contracting inspectors and specialists

7.6. General considerations

Application date: Issue No.: 04

Application date: Issue No.: 04