Legal Counselling

06 steps for inspection of GMP compliance in Vietnam

08:55, 04/01/2019

The Ministry of Health of Vietnam issued Circular No. 35/2018/TT-BYT on Good Manufacturing Practices (GMP) for pharmaceutical products and pharmaceutical starting materials.

According to Circular No. 35/2018/TT-BYT of the Ministry of Health of Vietnam, procedures for inspection and classification of GMP compliance include 06 steps, to be specific:

- Step 1. The inspectorate shall publish the decision on inspectorate establishment, purposes, contents and plan for the inspection at the manufacturer;

- Step 2. The manufacturer shall make a brief introduction of its organizational structure, personnel and implementation or application of GMP, or specific contents in conformity with the inspected contents;

- Step 3. The inspectorate shall carry out a site inspection of the application of GMP at the manufacturer;

- Step 4. The inspectorate shall have a talk with the manufacturer about deficiencies found during the inspection (if any) and assess the level of each deficiency; discuss with the manufacturer in case the manufacturer does not agree with the inspectorate about the assessment of each deficiency or level of GMP compliance;

- Step 5. An inspection record is prepared and signed;

- Step 6. The inspection record is completed.

View more details at Circular No. 35/2018/TT-BYT of the Ministry of Health of Vietnam, effective from January 10, 2019.

- Thanh Lam -

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