Circular No. 14/2012/TT-BYT stipulates the principles and standards of "Good Manufacturing Practices for Pharmaceutical Packaging" (GMP for pharmaceutical packaging) and provides guidance on implementation and application.

CIRCULAR

Regulations on Good Manufacturing Practice Principles and Standards for Pharmaceutical Packaging Production

and Implementation Guidelines

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Pursuant to the Medicine Law No. 34/2005/QH11 dated June 14, 2005;

Pursuant to Decree No. 188/2007/NĐ-CP dated December 27, 2007 of the Government on the functions, tasks, powers, and organizational structure of the Ministry of Health;

Pursuant to Decision No. 43/2007/QĐ-TTg dated March 29, 2007 of the Prime Minister approving the Project "Development of the Pharmaceutical Industry and Construction of a Model System for Drug Supply in Vietnam from 2007 to 2015 with Vision to 2020";

Considering the proposal of the Director of the Department of Medicines Administration,

The Ministry of Health issues this Circular regulating Good Manufacturing Practice Principles and Standards for Pharmaceutical Packaging Production and providing guidelines for implementation as follows:

Section I

GENERAL PROVISIONS

Article 1. Scope of Regulation

This Circular regulates Good Manufacturing Practice Principles and Standards for Pharmaceutical Packaging Production and provides guidelines for implementing these principles and standards in the production of pharmaceutical packaging that directly contacts drugs.

Article 2. Applicability

This Circular applies to establishments producing and trading pharmaceutical packaging that directly contacts drugs and establishments producing drugs circulating in the Vietnamese market.

PART II

GOOD MANUFACTURING PRACTICE PRINCIPLES AND STANDARDS FOR PHARMACEUTICAL PACKAGING PRODUCTION AND IMPLEMENTATION GUIDELINES

"DRUGS" AND GUIDELINES FOR IMPLEMENTATION AND APPLICATION

Article 3. Good Manufacturing Practice Principles and Standards for Pharmaceutical Packaging

The Good Manufacturing Practice Principles and Standards for Pharmaceutical Packaging Production are specified in Appendix 1 and Appendix 2 attached to this Circular.

Article 4. Organization of Implementation

1. The Department of Medicines Administration shall take the lead and coordinate with relevant units to disseminate the Good Manufacturing Practice Principles and Standards for Pharmaceutical Packaging Production (hereinafter referred to as GMP for Pharmaceutical Packaging), the list of GMP for Pharmaceutical Packaging inspection items, and guidelines for implementing and applying GMP for Pharmaceutical Packaging to provincial and municipal health services under the central government, health services of various sectors, and establishments producing pharmaceutical packaging that directly contacts drugs.

2. Establishments producing pharmaceutical packaging that directly contacts drugs wishing to apply for inspection to obtain a GMP for Pharmaceutical Packaging Certificate:

a) Study and train staff on the GMP for Pharmaceutical Packaging Principles and Standards, the list of GMP for Pharmaceutical Packaging inspection items, and related regulations.

b) Based on the GMP for Pharmaceutical Packaging Principles and Standards, scale, resources, and development orientation to implement appropriately according to the actual situation at the establishment.

c) Using the GMP for Pharmaceutical Packaging Inspection List (Appendix 3) to develop their own self-inspection list and conduct self-inspections to identify deficiencies and address existing issues.

Article 5. Registration for inspection

Article 5. Application for Inspection

Establishments producing pharmaceutical packaging wishing to apply for inspection to obtain a GMP for Pharmaceutical Packaging Certificate after self-inspection and evaluation as meeting GMP for Pharmaceutical Packaging requirements shall submit one set of application documents directly or by mail to the Department of Medicines Administration - Ministry of Health.

Contents of the application for inspection:

1. In case of first-time application for inspection:

a) Application form for GMP for Pharmaceutical Packaging inspection (Appendix 4 - Form 1);

b) Copy of the establishment's founding decision or business registration certificate or investment certificate confirmed by the establishment;

c) Organizational structure diagram (including names, professional qualifications of key personnel);

d) Factory layout and quality control and storage area diagrams (including overall factory layout; employee, raw material, semi-finished product movement diagrams; cleanroom layout for production and testing areas; equipment layout, etc.);

đ) Training and education program, materials, and summary report on GMP for Pharmaceutical Packaging training at the establishment;

e) List of equipment (production, testing, and storage) currently available and planned products;

g) Self-inspection report of the establishment for the most recent period (within three months).

2. In case of re-application for inspection:

At least two months before the expiration date of the GMP for Pharmaceutical Packaging compliance certificate, the establishment shall submit the re-inspection application documents. After submitting the re-inspection application, the establishment may continue production within the scope defined in the certificate.

Contents of the re-inspection application:

a) Re-inspection application form for GMP for Pharmaceutical Packaging (Appendix 4 - Form 2);

b) Report on addressing previous inspection findings;

c) Summary report on establishment activities over the past three years;

d) Report on changes at the establishment over the past three years of implementing GMP for Pharmaceutical Packaging (if any);

đ) Self-inspection report of the establishment for the most recent period (within three months).

Article 6. Competence, Procedure, and Process for Accepting, Reviewing Applications, Inspecting, and Issuing Certificates Meeting GMP Principles and Standards for Pharmaceutical Packaging

1. Competence

The Drug Administration is responsible for accepting and reviewing registration inspection applications, forming inspection teams, organizing on-site inspections, processing inspection results, and issuing certificates meeting GMP principles and standards for pharmaceutical packaging to production facilities.

2. Procedure and Process

a) After receiving complete registration inspection applications from the facility in accordance with Article 5, the Drug Administration will proceed to review the application.

b) Within five working days from the date of receipt of the application and the review fee as stipulated currently, the Drug Administration must notify the facility in writing about the inspection plan or the status of the application not meeting requirements.

c) Within twenty working days from the date of notification of the inspection plan, the Drug Administration must issue a decision to form the inspection team and conduct the actual inspection.

Article 7. Inspection, Processing Inspection Results, and Issuing Certificates Meeting GMP Principles and Standards for Pharmaceutical Packaging

1. Composition of the Inspection Team

The inspection team consists of the Team Leader, the Team Secretary (from the Drug Administration), and members (representatives from the Central Institute for Pharmaceutical Control or the Ho Chi Minh City Institute of Pharmaceutical Control, representatives from the Health Department of the province or centrally governed city where the inspected pharmaceutical packaging production facility is located, and may include representatives from the Drug Administration).

2. Criteria for Inspectors

a) Inspectors must have a bachelor's degree or higher; possess knowledge and experience in GMP inspections, be well-versed in GMP principles and standards, and have been trained in GMP and GMP inspection and audit.

b) They must employ scientific, resolute inspection methods capable of quickly identifying deficiencies at the facility while being able to propose convincing measures to help the facility address shortcomings.

c) They must be honest, impartial, and strictly adhere to all regulations and laws during the inspection process.

d) They must be in good health and not suffering from infectious diseases.

3. Inspection

a) The inspection team is responsible for inspecting all activities of the pharmaceutical packaging facility that directly interact with drugs according to GMP principles and standards for pharmaceutical packaging and current professional regulations:

- Step 1: Announce the Decision to Form the Inspection Team.

- Step 2: The production facility presents its implementation of GMP for pharmaceutical packaging; self-inspection results; reports on operational conditions, changes over the past three years since implementation, and corrective actions taken following previous inspections (in cases of re-inspection); explain and clarify issues as requested by the inspection team.

- Step 3: The inspection team conducts on-site evaluations (factories, quality control areas, storage areas, auxiliary facilities) and reviews relevant documents and records. - Step 4: Discuss and finalize the inspection report.

b) The inspection report must clearly identify deficiencies in the implementation of GMP for pharmaceutical packaging, conclude on the level of compliance with GMP principles and standards for pharmaceutical packaging. In cases where the production facility disagrees with the inspection team's opinion, the report must record all reservations expressed by the facility. The report is signed and confirmed by the facility manager, the team leader, and the team secretary; it is made in three copies, one copy retained by the facility, two copies retained by the Drug Administration.

4. Processing Inspection Results and Issuing Certificates.

a) If the inspected facility meets GMP principles and standards for pharmaceutical packaging, the Drug Administration must issue a certificate to the facility within five working days from the end of the inspection.

The certificate meeting GMP principles and standards for pharmaceutical packaging is valid for three years from the date of issuance.

b) If the inspected facility generally meets GMP principles and standards for pharmaceutical packaging but has some deficiencies that do not affect product quality and can be corrected in a short time, the inspection team requires the facility to correct and repair these deficiencies and report the results back to the Drug Administration within two months from the end of the inspection.

Within five working days from the date of receipt of the correction report, the Drug Administration must issue a certificate meeting GMP principles and standards for pharmaceutical packaging to the facility if the correction report meets requirements, or must notify the facility in writing about the non-compliance of the report.

More than two months from the end of the inspection, if the facility does not submit a valid correction report, it must apply for an inspection as if applying for an initial inspection and pay the prescribed fee.

c) If the inspected facility does not meet GMP principles and standards, the facility must correct and repair the deficiencies identified in the inspection report. After self-assessment and confirmation of compliance, the facility must apply for an inspection as if applying for an initial inspection and pay the prescribed fee.

Article 8. Inspection, examination, and handling of violations

1. The activities of inspection and examination to assess compliance with GMP packaging principles and standards shall be conducted regularly every three years or on an ad hoc basis upon request from the entity or at the requirement of the competent authority by the Ministry of Health (the Drug Administration Department).

2. During the inspection process, if serious violations affecting product quality are discovered, the head of the inspection team shall require the entity to temporarily halt production, prepare a record, and report to the authorized person for issuing a formal decision on handling.

Article 9. Implementation Plan

1. Entities producing direct contact pharmaceutical packaging must apply GMP packaging principles and standards. The Ministry of Health shall issue specific policies and appropriate regulations to promote the implementation and application of GMP packaging principles and standards.

2. The Ministry of Health requires entities producing drugs to use packaging that meets quality standards, controls material components, and ensures hygiene.

3. The Vietnam Pharmacopoeia Council shall take the lead and coordinate with the Central Institute for Pharmaceutical Control, the Ho Chi Minh City Institute for Pharmaceutical Control, and the National Institute for Vaccine and Biomedical Product Quality Control to develop and submit to the competent authority for promulgation quality standards for types of direct contact drug packaging so that drug production and distribution entities and direct contact drug packaging production and distribution entities have a basis for implementation.

4. The Drug Administration Department shall take the lead and coordinate with relevant units to strengthen post-inspection work, enhance the effectiveness of pre-inspection activities, ensure the use of pharmaceutical packaging that meets quality standards and is suitable for the dosage form and physicochemical and microbiological characteristics of the drug; particularly focusing on types of packaging that significantly impact drug quality such as non-rinseable packaging before use, packaging for sterile products like injectables, intravenous infusions, eye drops, nasal sprays, packaging for products containing unstable active ingredients, oral medications, and difficult-to-inspect quality component packaging like glass and plastic containers.

5. Implementation timeline

a) As of April 1, 2013, entities producing drugs circulating in the market shall only use primary packaging that cannot be rinsed prior to use, such as roll packaging (aluminum foil, PVC film), and spray nozzle packaging from entities meeting GMP packaging principles and standards. Each batch of packaging used must be accompanied by a test certificate and original label from the manufacturer.

b) As of January 1, 2014, entities producing drugs circulating in the market shall only use primary packaging from entities meeting GMP packaging principles and standards for other types of packaging. Each batch of packaging used must be accompanied by a test certificate and original label from the manufacturer.

Prior to these deadlines, the Ministry of Health encourages entities producing drugs circulating in the market to use products from entities meeting GMP packaging principles and standards.

Article 10. Provisions on implementation

1. This Circular takes effect from October 15, 2012.

2. The Heads of the Office, the Director of the Drug Administration Department, the Heads of units under the Ministry of Health, the Directors of Provincial Health Departments, the Heads of health sectors, and related organizations and individuals are responsible for implementing this Circular.

3. In case of difficulties, obstacles, or new issues arising during implementation, organizations and individuals are requested to report to the Ministry of Health (Drug Administration Department) for timely consideration and resolution./.