Thông tư 14/2012/TT-BYT

CIRCULAR

ON THE PRINCIPLES AND STANDARDS OF “GOOD MANUFACTURING PRACTICE OF PHARMACEUTICAL PACKAGING”, AND GUIDING ITS APPLICATION

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

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

Pursuant to the Prime Minister’s Decision No. 43/2007/QĐ-TTg dated March 29, 2007, approving the Scheme “Developing the pharmaceuticals industry and the medicine dispensary system of Vietnam during 2007 – 2015 and towards 2020”;

At the proposal of the Director of the Drug administration of Vietnam,

The Ministry of Health promulgates the Circular on the principles and standards of “Good manufacturing practice of pharmaceutical packaging”, and guides the application as follows:

Section I

GENERAL PROVISIONS

Article 1. Scope of regulation

This Circular provides for the principles and standards of “Good manufacturing practice of pharmaceutical packaging”, and guides the application of such principles and standards to the production of packages that directly contact the medicines.

Article 2. Subjects of application

This Circular is applicable to the facilities producing and trading packages in physical contact with drugs, and the facilities producing medicines that circulate on the Vietnam’s market.

Section II

PRINCIPLES AND STANDARDS OF “GOOD MANUFACTURING PRACTICE OF PHARMACEUTICAL PACKAGING”, AND GUIDES TO APPLICATION

Article 3. Principles and standards of “Good manufacturing practice of pharmaceutical packaging”

The principles and standards of “Good manufacturing practice of pharmaceutical packaging” are specified in Annex 1 and Annex 2 enclosed with this Circular.

Article 4. Implementation organization

1. The Drug administration of Vietnam shall be in charge and cooperate with relevant units to disseminate the principles and standards of “Good manufacturing practice of pharmaceutical packaging” (hereinafter referred to as GMP of pharmaceutical packaging), the list of GMP of pharmaceutical packaging inspection, and guide the application of GMP of pharmaceutical packaging for the Services of Health of central-affiliated cities and provinces, the Health agencies and facilities that produce packages in physical contact with drugs.

2. Facilities producing packages in physical contact with drugs wishing to apply for inspection in order to be issued with the GMP Certificate of pharmaceutical packaging:

a) Studying and providing training in principles and standards GMP of pharmaceutical packaging and the list of GMP of pharmaceutical packaging inspection, and the relevant provisions for officers and employees in the facility.

b) Applying appropriately based on the principles and standards of GMP of pharmaceutical packaging, the scale, the resources and development orientation.

c) Making the list of internal inspection, and carrying out internal inspection to detect and remedy the shortcomings based on the list of GMP of pharmaceutical packaging inspection (Annex 3).

Article 5. Application for inspection

Facilities producing packages wishing to apply for inspection in order to be issued with the GMP Certificate of pharmaceutical packaging, after having carried out internal inspection and meet the standards of GMP of pharmaceutical packaging, shall send 01 application for inspection to the Drug administration of Vietnam – the Ministry of Health directly or by post.

The composition of the application for inspection:

1. For first application:

a) The application sheet for GMP of pharmaceutical packaging inspection (Annex 4 – form 1);

b) The copy of the Establishment Decision or the Certificate of business registration, or the Investment certificate, certified by the facility;

c) The personnel plan (including the full names and credentials of senior officers);

d) The facility diagram and the quality inspection and preservation areas (including the overall plan, the paths, initial materials, semi-finished products, decontamination process of the production area and laboratory; the arrangement of machinery and equipment…)

dd) The program, materials and brief reports on the training in GMP of pharmaceutical packaging at the facility;

e) The list of current equipment (for production, tests, and preservation) and anticipated products;

g) The report on the nearest internal inspection (within 03 months).

2. Application for reinspection:

02 months before the GMP Certificate of pharmaceutical packaging expires, the facility must apply for reinspection. After submitting the application for reinspection, the facility is still allowed to produce in accordance with the certificate.

The application for reinspection includes:

a) The application sheet for GMP of pharmaceutical packaging reinspection (Annex 4 – form 2);

b) The report on remedying the shortcomings in the previous inspection;

c) The summary report on the operation of the facility over the previous 03 years;

d) The report on the changes of the facility over 03 years of applying GMP of pharmaceutical packaging (if any).

dd) The report on the nearest internal inspection (within 03 months).

3. Facilities wishing to add new production lines shall submit the application similarly to the first time (as prescribed in Clause 1 Article 5). In case the GMP certificate is unexpired but the facility needs inspection together with applying for inspection to add new production lines, the facility may apply for reinspection (as prescribed in Clause 2 Article 5) together with applying for  inspection to add new production lines.

Article 6. Authority, order, procedures for receiving, appraising, inspecting and issuing GMP Certificates of pharmaceutical packaging

1. Authority

Drug administration of Vietnam is responsible for receiving and appraising applications for inspection, establishing Inspectorates, organizing on-site inspection, handling inspection results, and issuing GMP Certificates of pharmaceutical packaging to facilities producing packages.

2. Order and procedures

a) After receiving the complete application for inspection from the facility as prescribed in Article 5, the Drug administration of Vietnam shall appraise the application.

b) Within 05 working days as from receiving the application and appraisal fee as prescribed by current law provisions, the Drug administration of Vietnam must send written notification to the facility about the inspection plan, or about the incomplete application.

c) Within 20 working days as from notifying the inspection plan, the Drug administration of Vietnam must make decisions on establishing the Inspectorate and carrying out on-site inspection.

Article 7. Inspecting, handling inspection results and issuing the GMP Certificate of pharmaceutical packaging

1. The composition of the Inspectorate

The Inspectorate includes the Chief Inspector, the Secretary (from the Drug administration of Vietnam) and the members (representatives from the National Institute of Drug Quality Control or the Institute of Drug Quality Control of Ho Chi Minh city, representatives from Services of Health of central-affiliated cities and provinces  where the facility is situated, or more representative from the Drug administration of Vietnam)

2. Standards of inspectors

a) The inspectors must have higher education degrees; have knowledge and experience in GMP inspection, grasp the principles and standards of GMP, and have been trained in GMP and GMP inspection.

b) Having scientific method for inspection that is able to detect faults of the facility, and to provide remedial measures.

c) Honest, objective, and strictly obeying the regulations and law provisions during the inspection.

d) Healthy and not suffering from infectious diseases.

3. Inspection

a) The Inspectorate must inspect every activity of the facility that produces packages in physical contact with drugs according to the principles and standards of GMP of pharmaceutical packaging and current professional provisions:

- Step 1: Notifying the Decision on establishing the Inspectorate.

- Step 2: Production facilities shall present the application of GMP of pharmaceutical packaging; the internal inspection results, the reports on the operation and changes of the facilities over 03 years of application, and the remedy of the faults detected in the previous inspection (for reinspection); explain the issues at the request from the Inspectorate.

- Step 3: The Inspectorate shall carry out on-site inspection (the workshop, the quality inspection area, the preservation areas, the ancillary services), and inspect the relevant documents and materials.

- Step 4: Discussing and unifying in the inspection record.

b) The inspection record must specify the shortcomings during the application of GMP of pharmaceutical packaging, the conclusion about the fulfillment of the principles and standards of GMP of pharmaceutical packaging. If the facility does not concur with the opinion given by the Inspectorate, the record must specify every dissenting opinion given by the facility. The record must be signed by the person in charge of the facility, the Chief Inspector, and the Inspectorate secretary; made into 03 copies, 01 copy is kept by the facility, 02 copies are kept at the Drug administration of Vietnam.

4. Handling inspection results and issuing Certificates.

a) If the facility satisfies the principles and standards of GMP of pharmaceutical packaging, the Drug administration of Vietnam must issue the Certificate to the facility within 05 working days after the inspection.

The GMP Certificate of pharmaceutical packaging is valid for 03 years as from the date of signing.

b) If the inspected facility basically satisfies the principles and standards of GMP of pharmaceutical packaging, and the remaining shortcomings do not affect the product quality and may be rectified within a short period of time, the Inspectorate shall request the facility to rectify the shortcomings and report the results to the Drug administration of Vietnam within 2 months after the inspection.

Within 05 working days as from receiving the rectification report, the Drug administration of Vietnam must issue the GMP Certificate of pharmaceutical packaging to the facilities if the rectification is satisfactory, or notify the facility of the unfulfillment of the report.

After 02 months after the inspection, if the facility fails to send the valid rectification report, is must apply for inspection similarly to the first time, and pay inspection fee as prescribed.

c) If the facility does not satisfy the principles and standards of GMP, it must rectify the shortcomings stated in the inspection record. After the internal assessment, the facility shall apply for the inspection similarly to the first time, and pay inspection fee as prescribed.

Article 8. Inspection and handling violations

1. The inspection and assessment of the conformity with the principles and standards of GMP of pharmaceutical packaging must be carried out by the Ministry of Health (the Drug administration of Vietnam) every 03 years or irregularly at the request of the facility or functional agencies.

2. During the inspection, if the Inspectorate discovers that the facility is committing violations that seriously affect the product quality, the Chief Inspector shall request the facilities to suspend the production, and send a report to competent persons for official decisions.

Article 9. Application plan

1. Facilities that produce packages in physical contact with drugs must study and apply the principles and standards of GMP of pharmaceutical packaging. The Ministry of Health shall promulgates specify policies and appropriate provisions for boosting the application of the principles and standards of GMP of pharmaceutical packaging.

2. The Ministry of Health shall request the drug production facilities to use packages that meet the quality standards, control the materials, and ensure the hygiene.

3. The Vietnam’s Pharmacopoeia Council shall be is charge and cooperate with the National Institute of Drug Quality Control and the Institute of Drug Quality Control of Ho Chi Minh city, the National Institute of Vaccine and Medical Test, in formulating and submitting the quality standards of packages in physical contact with drugs to competent authorities for promulgation in order to form the basis for the facilities producing, trading medicines, and the facilities producing, trading packages in physical contact with drugs to implement.

4. The Drug administration of Vietnam shall be in charge and cooperate with relevant units in enhancing the post-inspection works, improving pre-inspection activities, ensuring the use of quality pharmaceutical packages that are suitable for the preparation and the chemical, physical, and microbiological property of the medicines; paying attention on the packages that considerably affect the drug quality, such as packages not being cleaned before use, packages of sterile medicines such as injection drugs, eye-drops, nose drops, packages of drugs that contain active ingredients, oral medications, or packages that are hard for quality inspection such as glass or plastic packages.

5. Application roadmap

a) From April 01, 2013, the facilities that produce drugs circulating on the market only use the primary packages (level 1), being the packages uncleanable before use such as rolled packages (aluminum foil or PVC foil) and syringe from facilities that meet the principles and standards of GMP of pharmaceutical packaging. The package batches must be enclosed with the test certificate and original labels of the producers.

a) From April 01, 2014, the facilities that produce drugs circulating on the market only use the primary packages, for other kinds of packages from facilities that meet the principles and standards of GMP of pharmaceutical packaging. The package batches must be enclosed with the test certificate and original labels of the producers.

c) Before such times, the Ministry of Health must encourages facilities that produce circulating drugs to use the products from facilities that meet the principles and standards of GMP of pharmaceutical packaging.

Article 10. Implementation provisions

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

2. The Chief officers, the Director of the Drug administration of Vietnam, Heads of units affiliated to the Ministry of Health, Directors of Services of Health of central-affiliated cities and provinces, Heads of Health agencies, and relevant organizations and individuals are responsible for implementing this Circular.

3. Organizations and individuals are recommended to send feedbacks on the difficulties arising during the course of implementation to the Ministry of Health (the Drug administration of Vietnam) for consideration and settlement./.