Vietnam: 07 cases of surprise inspection of GMP compliance at the manufacturer

08:54, 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, amending Circular No. 04/2018/TT-BYT.

According to Circular No. 35/2018/TT-BYT of the Ministry of Health of Vietnam, from January 10, 2019, an surprise inspection of GMP compliance and maintenance thereof shall be carried out at the manufacturer in one of the following cases:

- The result of deficiency rectification by the manufacturer shows it still fails to comply with GMP according to Sub-point 2 Point c Clause 6 Article 11 of this Circular;

- The manufacturer that complies with GMP at level 3 or level 4 according to Points c and d Clause 3 Article 7 of this Circular shall undergo an surprise inspection at least once within 03 (three) years from the end of the previous inspection;

- The manufacturer has at least 01 batch of pharmaceutical products which is recalled because of first-degree violations;

- The manufacturer has a pharmaceutical product that is reported to have adverse effects, including serious ones;

- The inspecting authority concludes that the manufacturer seriously violates GMP;

- There is any complaint or denunciation that the manufacturer seriously violates GMP;

- The manufacturer fails to submit the operation and GMP compliance report according to Clause 5 Article 9 of this Circular.

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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