Circular 14/2012/tt-Byt: Regulating The Principles, Standards Of "good Manufacturing Practice Pharmaceutical Packaging" And Deployment Guides, Apply

Original Language Title: Thông tư 14/2012/TT-BYT: Quy định các nguyên tắc, tiêu chuẩn “Thực hành tốt sản xuất bao bì dược phẩm” và hướng dẫn triển khai, áp dụng

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MINISTRY OF HEALTH
Number: 14 /2012/TT-BYT
THE SOCIALIST REPUBLIC OF VIETNAM.
Independence-Freedom-Happiness
Hanoi, August 31, 2012

IT ' S SMART

Regulation of Principles, Standards "Good Practice Production of Pharmaceutical packaging"

and the deployment guide, apply

________________________

The Code of Pharmacy. 34 /2005/QH11 14 June 2005;

Base of Protocol 188 /2007/NĐ-CP December 27, 2007 the Government regulates the functions, duties, powers, and organizational structure of the Ministry of Health;

Base Decision Base 43 /2007/QĐ-TTg April 29, 2007, the Prime Minister's March 29, 2007 review of the Project "Development of Pharmacy and Building the Model of Vietnam Drug Supply Systems 2007-2015 and Vision 2020";

At the suggestion of the Director of the Bureau of Pharmacology,

The Ministry of Health issued the Ministry of Information that regulates the principles, the standard "Good Practice Production of Pharmaceutical packaging" and instructs the deployment, as applicable as follows:

Item I

GENERAL REGULATION

What? 1. The adjustment range

This information regulates the principles, the standard "Good Practice Production of Pharmaceutical packaging" and instructs the deployment, applying the principles, the standard "Good Practice of the Product packaging" in the field of packaging of direct contact with the product of the product. Medicine.

What? 2. Subject applies

The information applies to manufacturing facilities, the packaging business that is directly exposed to the drug and the production facilities in the Vietnamese market.

Section II

THE STANDARD PRINCIPLE "GOOD PRACTICE OF PRODUCT PACKAGING" AND THE IMPLEMENTATION OF THE IMPLEMENTATION APPLY.

What? 3. The standard principle of "Good Practice of Pharmaceutical packaging"

The n The standard, standard "Practice of the Good Practice of Pharmaceutical packaging" is regulated at Annex 1 and Appendix 2 this message.

What? 4. Organization

1. The presiding officer of the Pharmaceutical Management, in collaboration with the relevant organization units that populate the principles, the standard "Good Practice Production of Pharmaceutical packaging" (later known as the pharmaceutical packaging GMP), the pharmaceutical packaging portfolio and deployment guide, application of the GMP packaging to the Department of Health of the Provinces, the Central City of the Central, Health of the Industry and the facilities that produce direct contact with the drug.

2. The packaging facilities that are directly exposed to the drug have the need to register for inspection to grant the Pharmaceutical packaging certification:

a) Research and training of principles, GMP standard of pharmaceutical packaging and portfolio of drug packaging and related regulations for cadres, employees in the facility.

b) Base of the principles, GMP standard of pharmaceutical packaging, scale, resources, and development orientation to apply. consistent with reality deployed at the facility .

c) Based on the checklist GMP (Annex 3) to build the self-examination portfolio of the facility and conduct self-examination to detect defects and rectify the existence.

What? 5. Subscription Register

Packaging manufacturing facilities have a need to register for inspection to issue a GMP Certificate of Pharmaceutical packaging after self-checking, evaluation to GMP packaging of pharmaceuticals, directly filed or sent in a postal route 1 set of registration records to the Department of Pharmacy Management-Ministry of Medicine Yeah.

Audit registration file component:

1. First Test registration case:

a) The registration of the Pharmaceutical packaging GMP (Annex 4-Template 1);

b) A copy of the decision to establish a facility or a Business Registration Certificate or Certificate of Investment Certificate of the facility;

c) Preliminary organization schemes (including them, names, qualifications of key cadres);

d) A factory map and quality test areas, preservation (including a master factory diagram; employee path diagram, original raw materials, semi-finished materials; manufacturing cleaners, test rooms; machine layout schemes, equipment, etc.);

) Program, documentation and summary report on training, GMP training of pharmaceutical packaging at the facility;

e) Equipment category (production, testing, and preservation) is available and the product is expected to produce;

g) The self-inspection report of the nearest outbreak base (within 3 months).

2. The case of registration reexamination:

Prior to 2 months as of the date of the Certificate of Identification, the standard pharmaceutical GMP standard expired, the conduct of the process filed for re-examination registration. The facility after having filed a re-examination registration case is still allowed to produce according to the specified scope in the Certificate.

Reaudit registration file component:

a) Subscriptions for retesting GMP packaging (Annex 4-Template 2);

b) The remediation report exists in the previous examination;

c) The operational summary report of the facility in the last 3 years;

d) Report the changes of the base in the 03 years of the implementation of the pharmaceutical packaging GMP (if available).

) Report on the basis of the nearest outbreak facility (within 3 months).

3. The facility with the need to add a new chain file file registration as the first test register (prescribed at paragraph 1, Article 5). The case of a GMP certificate is not expired but the facility with a need for a re-examination with a new chain plugin checklist can file a re-examination registration (prescribed at paragraph 2, Article 5) simultaneously with the registration of the wire plugin. New pass.

What? 6. Authority, sequence, certification procedure, case appraisal, examination, and level of certificates that receive the principle, the GMP standard of pharmaceutical packaging

1. Authority

The Bureau of Pharmacology is responsible for receiving and appraisal of the test registration records, the corporation and the actual examination organization, handling the results after the examination and granting the Certificate of Certificates To The Principle, the GMP standard of pharmaceutical packaging for the packaging facility.

2. The sequence, procedure.

a) After receiving enough audit registration records of the prescribed facility at Article 5, the Department of Pharmacology conducts the case appraisal.

b) Within the 5 working days since receiving records and appraisal charges under the current regulation, the Bureau of Pharmacology must inform the agency about the test plan or condition status that has not yet reached the request.

c) Within 20 working days since the announcement of the inspection plan, the Bureau of Pharmacy must decide to form a delegation, conduct a practical examination.

What? 7. Check out the test results and grant the Certificate Certificate in principle, the GMP standard of pharmaceutical packaging.

1.

The inspection team includes the Head of the Division, the Secretary of the Department (Bureau of Pharmacology) and its members (representing the Central Drug Testing Institute or Ho Chi Minh City Control Institute, representing the Provincial Health Department, the Central City of Central City where the facility is located. produce registration of the pharmaceutical packaging GMP packaging and may have additional representative of the Department of Pharmacology.

2. Standards of audit staff

a) The inspection officer must have a higher degree of higher education; there is knowledge, experience of the GMP examination, which holds the principles, the GMP standard, which has been training training on GMP and inspectors, the GMP test.

b) There is a method of inspection, scientific examination, erection, the ability to quickly detect the errors of the facility and the ability to provide a compelling measure to help the recovery facility.

c) The true, objective, objective, objective, and the strictest of the rules, the rule of law in the process of examination.

d) There is enough health, not contracting infectious diseases.

3. Check

a) The inspection team is responsible for examining the entire operation of the packaging facility directly exposed to drugs according to the principles, the pharmaceutical packaging standard GMP, and current professional regulations:

- Step 1 : The decision to establish the inspection team.

- Step 2 : The production facility presents the process of deploying the GMP packaging; the results of self-inspectors; report the operational situation, the changes of the facility after 3 years of deployment and the result of overcoming the existence of the previous test (in the case of re-registration). examination); explained, clarify matters at the request of the inspection team.

- Step 3 : The inspection team conducts actual evaluation (workshop, quality inspection area, preservation, auxiliary utilities) and examination of the records, documents relevant.

- Step 4 : Discussion, unified through the inspection.

b) The audit editor must specify only the existence of the implementation of the pharmaceutical packaging GMP, which concluded the level of the principle response, the GMP standard of pharmaceutical packaging. In the case of the production base that is not unanimous with the opinion of the inspection team, the border must record all the maintenance opinions of the facility. The editor was in charge of the company's chief of the company and the secretary of the examination; it made 3 copies, 01 copies at the facility, 2 records at the Bureau of Pharmacology.

4. Processing the results after examination and level of certificates.

a) If the facility is tested to meet the principles, the GMP standard of pharmaceutical packaging, the Department of Pharmacology must issue a Certificate of Certificate for the facility within the five days of work since the end of the examination.

The certificate is in principle, the GMP standard of pharmaceuticals is valid for 3 years from the date of the signing.

b) If the underlying test base meets the principles, the GMP-packaging standard of pharmaceuticals and also some exist but does not affect the quality of the product, which can be overcome in short time, the Corps requires the facility to rectify, repair and repair. Fixing and reporting the results of the existence of the existence of an inspection team have been on the receipt to the Department of Pharmacy within two months of the end of the examination.

Within 05 working days since receiving a recoverable report, the Bureau of Pharmacology must grant the Certificate of Identification, the GMP standard of pharmaceutical packaging for the facility if the recalculation report is required or must be informed by text to the knowledge base. The state of the report was not required.

It ' s just two months since the end of the test, if the facility does not submit a valid recoverable report it must proceed to register for a test registration as the first test registration and the prescribed fee filing.

c) If the facility is checked not to meet the principles, the GMP standard, the basis of repairing the existing existing exists in the audit editor. After your self-assessment is required, the facility conducts checkup as the first test registration and the prescribed fee filing.

What? 8. Inspector, check and dispose of the breach

1. Inspector-in-check, evaluation of compliance with principles, GMP standard of pharmaceutical packaging is conducted periodically every 03 years or bars, check-out-check on the basis of the facility or at the request of the authorities authorities (Department of Health Management). I ' ll do it.

2. During the inspection, if the basis of a breach of the facility has a serious impact on the quality of the product, the inspector general asks the facility to suspend the production, set up the editor, report the authority to the formal processing decision.

What? 9. The deployment plan

1. The packaging facilities are directly exposed to the study drug, which applies the principle, the GMP standard of pharmaceutical packaging. The Ministry of Health enacted specific policies and appropriate regulations aimed at promoting the deployment, implementation of the principle, the GMP standard of pharmaceutical packaging.

2. The Ministry of Health requires the facilities to produce the drug that must use the packaging that reaches the quality standard, which controls the material that is structured and guaranteed hygiene.

3. Vietnam Pharmacy Council chaired, in collaboration with the Central Drug Testing Institute, Ho Chi Minh City Drug Testing Institute, the National Review Institute for Vaccines and Constructive Medical Students and the competent authority to enact quality standards. of the packaging of the packaging directly with the drug for manufacturing facilities, drug business, and manufacturing facilities, the packaging business that is directly exposed to the existing base.

4. The presiding officer of the Pharmaceutical Management, in coordination with the relevant units of post-control work, enhance the efficiency of the payment operation, ensuring the use of packaging packaging pharmaceuticals to quality, in accordance with the form of organoplasm and specialization, reason, microbiology of the drug; special attention to the types of packaging that affects the quality of drugs such as the packaging that does not clean before use, the packaging packaging sterocides such as injections, injections, small, small nose, the packaging packaging that contains poor practices, oral medications, The packaging is difficult to test the substance of the structure as the packaging made of glass, plastics. .

5. Roadmap

a) Since April 1, 2013, the production facilities in the market are using only one type of first-grade packaging before being used as packaging packaging (aluminium membrane, PVC membrane), muscle sprays of the base, standard, and standard. GMP packaging. The packaging batches that use must be tested, the manufacturer's original label stamps are attached.

b) Since January 1, 2014, the production facilities in the market are using only one-grade packaging packaging for other packaging envelopes of the facility to be in principle, the GMP standard of pharmaceutical packaging. The packaging batches that use must be tested, the manufacturer's original label stamps are attached.

c) Before the time of the above stated, the Ministry of Health encouraged the basis of the production of the drug in the market to use the products of the base-reaching facilities, the GMP standard of pharmaceutical packaging.

What? 10. Terms of execution

1. This message has been in effect since October 15, 2012.

2. The Chief of Staff, Director of the Bureau of Pharmacology, the Chief of the Department of Health, Director of the Health Department of the Provinces, the Central City of Central, Health Minister of the Ministry of Health and organizations, the relevant individual is responsible for the enforcement of the Department of Health. Hey.

3. During the course of execution if there is difficulty, entangrium or related arise, recommended organizations, individuals report to the Ministry of Health (Bureau of Pharmacy) to promptly review, solve.

KT. MINISTER.
Chief.

(signed)

Ming Ming