GMP audit / inspection checklist
GMP — Good Manufacturing Practice Audit Checklist
- EN
- GMP — Good Manufacturing Practice Audit Checklist
- VI
- Checklist kiểm tra GMP — Thực hành tốt sản xuất thuốc
- JA
- GMP — 医薬品製造の優良基準監査チェックリスト
Medicine
Description
Audit checklist for Good Manufacturing Practice, applied to drug manufacturers. Vietnam adopts WHO-GMP, EU-GMP and PIC/S-GMP standards including biological-specific annexes. Segregated dedicated lines required for vaccines, biologicals containing live microorganisms, cytotoxics, betalactams, and sex hormones.
Legal basis
Circular 28/2025/TT-BYT (replaced TT 35/2018).
- Issuing authority
- Drug Administration of Vietnam (DAV)
- Format
- Other / multiple
- Last reviewed:
- 2026-06-28
- Page updated:
- 2026-06-28