Procedure for assessing compliance with Good Manufacturing Practices for drugs and pharmaceutical ingredients

Trình tự đánh giá việc đáp ứng Thực hành tốt sản xuất thuốc, nguyên liệu làm thuốc- Ảnh 1. — Circular clearly stipulates the procedure for assessing compliance with Good Manufacturing Practices for drugs and pharmaceutical ingredients.

This Circular provides for the promulgation, application and promulgation of principles and standards for Good Manufacturing Practices for drugs and pharmaceutical ingredients and the assessment and maintenance of compliance with Good Manufacturing Practices for drugs and pharmaceutical ingredients.

Procedure for assessing compliance with Good Manufacturing Practices for medicinal products

According to the Circular, the procedure for assessing compliance with Good Manufacturing Practices for drugs and pharmaceutical ingredients is as follows:

Receiving documents

The manufacturing facility shall directly or via postal service submit or online 1 set of documents as prescribed with appraisal fee as prescribed by the Minister of Finance on appraisal fee for production standards and conditions to the receiving agency of the Ministry of Health as follows:

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.

a- 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.

b- The Drug Administration of Vietnam for manufacturing establishments requesting to be granted a Certificate of eligibility for pharmaceutical business with the scope of only producing pharmaceutical ingredients (excluding medicinal herbs), chemical drugs, medicinal herbs, vaccines, and biological products at the time of application submission.

c- The Drug Administration of Vietnam for manufacturing establishments requesting to be granted a Certificate of eligibility for pharmaceutical business with the scope of simultaneously producing 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 submitting the application.

Procedure for receiving and processing documents

Upon receiving a complete application as prescribed, the Application Receiving Agency shall return to the requesting facility a Application Receipt according to Form No. 01 in Appendix I issued with Decree No. 163/2025/ND-CP.

Within 5 working days from the date of receiving valid documents, the Receiving Agency shall establish an Assessment Team and send to the production facility the decision to establish the Assessment Team, including the expected time for actual assessment at the production facility.

Within 7 working days from the date of the establishment decision and 3 working days for manufacturing facilities that produce drugs and pharmaceutical ingredients that are given priority in administrative procedures as prescribed in Clause 5, Article 7 of the Law on Pharmacy, the Assessment Team shall conduct an actual assessment at the manufacturing facility.

Actual assessment process at production facility

The Circular clearly stipulates the actual assessment process at the production facility:

Step 1. The assessment team announces the Decision to establish the assessment team, the purpose, content and expected assessment program at the production facility.

Step 2. The manufacturing facility briefly presents its organization, personnel, and activities in implementing and applying GMP (Good Manufacturing Practice) or specific content according to the content of the assessment.

Step 3. The assessment team conducts an actual assessment at the production facility 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 stages of production that the facility performs. The assessment program can be adjusted according to the actual implementation situation or the existing problems of the production facility discovered during the assessment process.

Step 4. The assessment team meets with the manufacturing facility to inform about any 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

After reaching an agreement with the facility, the Assessment Team shall prepare an 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, assessment form, 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 shall be made in 02 copies, of which 01 copy shall be kept at the production facility and 01 copy shall be kept at the receiving agency.

Step 6. Completing the GMP Assessment Report:

Within 5 working days from the date of signing the assessment record, the Assessment Team shall be responsible for preparing a GMP assessment report according to Form No. 04 specified in Appendix X issued with this Circular and sending it to the manufacturing facility. The GMP assessment report must list, analyze, and classify the level of existence that the manufacturing facility needs to overcome and repair; refer to the corresponding provisions of the legal document and GMP principles and standards, and assess the level of GMP compliance of the manufacturing facility. The classification of the level of existence and assessment of the level of GMP compliance of the manufacturing facility (specifically for each production line) are specified in Appendix IX issued with this Circular. The GMP assessment report shall be made in 02 copies, of which 01 copy is sent to the manufacturing facility and 01 copy is kept at the receiving agency.

Minh Hien

Source: https://baochinhphu.vn/trinh-tu-danh-gia-viec-dap-ung-thuc-hanh-tot-san-xuat-thuoc-nguyen-lieu-lam-thuoc-102250703111333876.htm