The Ministry of Health proposes regulations on assessment of compliance with Good Manufacturing Practices for drugs and pharmaceutical ingredients - Illustrative photo
Procedure for assessing compliance with Good Manufacturing Practices for drugs and pharmaceutical ingredients
Regarding receiving documents, according to the draft, the production facility shall submit 01 set of documents as prescribed with appraisal fees as prescribed by the Minister of Finance on appraisal fees for standards and production conditions to the receiving agency of the Ministry of Health as follows:
- Department of Traditional Medicine and Pharmacy Management for manufacturing establishments requesting to be granted a Certificate of eligibility for pharmaceutical business with the scope of only producing medicinal herbs, traditional medicines, and traditional medicinal ingredients at the time of application submission;
- The Drug Administration of Vietnam for manufacturing establishments requesting to be granted a Certificate of eligibility for pharmaceutical business with the scope of production of pharmaceutical ingredients (excluding medicinal herbs), chemical drugs, medicinal herbs, vaccines, biological products;
Good Manufacturing Practice is a set of principles and standards for the production of drugs and pharmaceutical ingredients to ensure that drugs and pharmaceutical ingredients are always produced and tested consistently according to quality standards appropriate to the intended use and requirements of the drug and pharmaceutical ingredient registration certificate.
- The Drug Administration of Vietnam shall grant a Certificate of eligibility for pharmaceutical business to a manufacturing facility that simultaneously produces one of the drugs and pharmaceutical ingredients specified in Point a of this Clause and one of the drugs and pharmaceutical ingredients specified in Point b of this Clause at the time of application submission.
The procedure for receiving and appraising dossiers shall comply with the provisions of Clause 2 and Clause 5, Article 33 of Decree No. 54/2017/ND-CP and Clause 12, Article 5 of Decree No. 155/2018/ND-CP.
The draft clearly states that within 05 days from the date of receiving valid documents, the Receiving Agency shall establish an Assessment Team and send to the production facility a decision to establish an Assessment Team, including the expected time for actual assessment at the production facility.
Within 15 days from the date of the decision to establish, the Assessment Team shall conduct an actual assessment at the production facility.
Procedure for assessing compliance and classifying compliance with Good Manufacturing Practices for drugs and pharmaceutical ingredients
The proposed evaluation process is as follows:
- Step 1. The assessment team announces the Decision to establish the assessment team, the purpose, content and assessment plan at the production facility;
- Step 2. The manufacturing facility briefly presents the organization, personnel, and activities of implementing and applying GMP or specific content according to the content of the assessment;
GMP is the abbreviation of the English phrase "Good Manufacturing Practices", translated into Vietnamese as "Good Manufacturing Practices".
- Step 3. The assessment team conducts an actual assessment of the implementation of GMP at the production facility according to each specific content. In case the facility performs one or several stages of the production process, the assessment content only includes requirements corresponding to one or several production stages that the facility performs;
- Step 4. The assessment team meets with the manufacturing facility to inform about the shortcomings discovered during the assessment process (if any); assess the level of each deficiency; discuss with the manufacturing facility in case the manufacturing facility does not agree with the assessment team's assessment of each deficiency or the level of compliance with GMP principles and standards of the manufacturing facility;
- Step 5. Prepare and sign the assessment report: Immediately after completing the actual assessment at the production facility, the Assessment Team shall prepare the assessment report according to Form No. 03 specified in Appendix X issued with this Circular. The assessment report must show the composition of the Assessment Team, the composition of the production facility, location, time, scope of assessment, and issues of disagreement between the Assessment Team and the production facility (if any). The leaders of the production facility and the Head of the Assessment Team shall sign the assessment report. The report is made in 02 copies: 01 copy is kept at the production facility, 01 copy is kept at the receiving agency.
- Step 6. Completing the Assessment Report: The assessment team is responsible for preparing a GMP assessment report according to Form No. 04 specified in Appendix X issued with this Circular, listing and analyzing, classifying the level of existence that the production facility needs to overcome and repair; referring to the corresponding provisions of legal documents and GMP principles and standards, assessing the level of GMP compliance of the production facility. The classification of the level of existence and assessment of the level of GMP compliance of the production facility (specifically for each production line) are specified in Appendix IX issued with this Circular.
GMP compliance level:
The level of GMP compliance of manufacturing facilities is specified in Appendix IX issued with this Circular, including the following levels:
- Manufacturing facility complies with GMP level 1.
- Manufacturing facility complies with GMP level 2.
- Manufacturing facility complies with GMP level 3.
- Manufacturing facility complies with GMP level 4.
Processing of assessment results to meet Good Manufacturing Practices for drugs and pharmaceutical ingredients
According to the draft, in case the GMP assessment report concludes that the manufacturing facility complies with GMP at level 1, within 10 working days from the date of signing the assessment report, the Receiving Agency shall submit to the Minister of Health a Certificate of eligibility for pharmaceutical business and issue a GMP Certificate according to Form No. 05 specified in Appendix X issued with this Circular if the manufacturing facility has made a request in the Application for a Certificate of eligibility for pharmaceutical business.
In case the GMP assessment report concludes that the manufacturing facility complies with GMP at level 2, within 05 working days from the date of signing the assessment report, the Receiving Agency shall send the GMP assessment report to the manufacturing facility as prescribed in Point b, Clause 6, Article 33 of Decree No. 54/2017/ND-CP. After completing the correction and repair, the manufacturing facility must have a written report on the correction including a plan and evidence (documents, images, videos, certificates or other supporting documents) to correct and repair the existing deficiencies recorded in the GMP assessment report. (*)
In case the GMP assessment report concludes that the manufacturing facility complies with GMP at level 3, the order and time for processing the GMP compliance assessment results shall be in accordance with the provisions (*) above. Within 20 days from the date of receipt of the corrective report, the Receiving Authority shall conduct an actual assessment of the corrective actions at the manufacturing facility before concluding the GMP compliance status of the manufacturing facility in accordance with the above provisions.
In case the GMP assessment report concludes that the manufacturing facility complies with GMP at level 4, within 05 working days from the date of signing the assessment report, the Receiving Authority shall issue a written notice of non-compliance with GMP, together with the GMP assessment report, to the manufacturing facility and shall not issue a Certificate of eligibility for pharmaceutical business.
In case the manufacturing facility disagrees with the existing problem as assessed by the Assessment Team, within 30 days from the date the Assessment Team has the GMP assessment report or the corrective action assessment report, the manufacturing facility shall send a written request to the Receiving Agency with evidence (documents, images, videos, certificates) proving the existence of that problem.
Within 10 working days from the date of receipt of the written request from the manufacturing facility, the Receiving Authority shall review the GMP assessment report, the content of the manufacturing facility's request, if necessary, consult with experts in the relevant field and respond in writing to the manufacturing facility. The written response must clearly state the content of approval or disapproval of the manufacturing facility's request, and the reason for disapproval. This period shall not be included in the assessment period.
Within 05 working days from the date of issuance of the Certificate of eligibility for pharmaceutical business, the receiving agency shall publish the following information on the Ministry of Health's Electronic Information Portal and the receiving agency's Electronic Information Page:
- Name and address of manufacturing facility;
- Full name of the person in charge of pharmaceutical expertise, the person in charge of quality assurance and the number of the Pharmacy Practice Certificate;
- Certificate of eligibility for pharmaceutical business number and GMP Certificate number (if any);
- Expiration date of GMP compliance assessment;
- Scope of operations of the production facility.
Please read the full draft and give your comments here.
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Source: https://baochinhphu.vn/danh-gia-dap-ung-thuc-hanh-tot-san-xuat-thuoc-nguyen-lieu-lam-thuoc-the-nao-102250313162747158.htm
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