A foreign-invested drug plant in Vietnam must meet Good Manufacturing Practice (GMP) aligned with WHO, PIC/S and EU standards, and compliance is not a one-off licensing event: the regulator reassesses the plant on a three-year cycle, with unannounced assessments where risk signals appear. This article sets out the assessment criteria, the cycle and the legal consequences of failing GMP.
Legal basis
- Law on Pharmacy 105/2016/QH14: Article 33 (facility, technical and personnel conditions of drug manufacturers) and Article 40 (revocation of the certificate of eligibility for pharmaceutical business).
- Circular 35/2018/TT-BYT on Good Manufacturing Practice for medicinal products and medicinal ingredients, including periodic and ad hoc GMP maintenance assessments.
- Decree 54/2017/ND-CP guiding the Law on Pharmacy on pharmaceutical business conditions and good-practice assessments.
What do assessors examine?
The assessment team of the Drug Administration of Vietnam (or the receiving authority under decentralisation) reviews the whole production system: premises and clean-zone grading with one-way flows preventing cross-contamination, utilities (purified water, compressed air, HVAC), calibrated and qualified production and laboratory equipment, the quality system (SOPs, batch records, change control, deviation handling, CAPA), GSP-compliant warehousing, and key personnel (the professional manager and QA/QC heads) meeting qualification requirements. For an FDI plant, the team also reconciles actual production against the scope recorded in the certificate of eligibility for pharmaceutical business: manufacturing outside the licensed scope is a serious finding even where the quality system is sound.
The cycle: three-year reassessment and the maintenance report
Facility, technical and personnel conditions are reassessed once every three years, or on an ad hoc basis. Each November the receiving authority reviews and publishes the periodic assessment plan for the following year. At least 30 days before the scheduled assessment, the plant must file a report on production activities and GMP maintenance in the prescribed form, with updated technical documents on facilities, equipment and personnel where changed. If the report is late, the authority issues a written request; the plant then has 45 days to file with an explanation, failing which an ad hoc assessment follows. A GMP certificate is valid for no more than three years from the latest assessment, so an FDI plant should plan backwards from that date.
What happens if the plant fails?
Findings are graded. Minor deficiencies that do not affect drug quality and can be corrected lead to a corrective plan and a follow-up review before certification is granted or maintained. Serious deficiencies, or failure to maintain GMP in a production scope, lead to revocation of the certificate of eligibility for pharmaceutical business for that scope under Article 40 of the Law on Pharmacy, meaning production in that scope must stop until reassessment and re-issuance. Substandard production can further attract administrative penalties in the health sector, cancellation of marketing authorisations for affected products and market recalls.
Practical recommendations for FDI plants
In practice, FDI plants most often stumble on three points: batch records and electronic data integrity not fully aligned with group standards, equipment or process changes not run through local change control, and changes of the professional manager not updated with the receiving authority. Run a mock inspection at least six months before each three-year cycle, treat the maintenance report as a standing compliance obligation, and do not wait for the published plan to start gap remediation.
Frequently asked questions
What are the GMP inspection criteria for a foreign-invested pharma plant?
Five groups: premises and utilities meeting GMP clean grades under WHO/PIC/S standards; calibrated and qualified production and laboratory equipment; the quality system (SOPs, batch records, change control, CAPA); GSP-compliant storage; and qualified key personnel. Assessors also reconcile actual production with the scope in the certificate of eligibility for pharmaceutical business.
How often are GMP inspections conducted?
Periodically once every three years, under a plan the receiving authority publishes each November for the following year. Ad hoc assessments may occur where the plant misses its maintenance-report deadline or where quality violations are suspected.
What happens if a plant fails GMP?
Minor, correctable findings require a corrective plan and follow-up review. Failure to maintain GMP in any scope leads to revocation of the certificate of eligibility for that scope under Article 40 of the Law on Pharmacy, suspension of that production scope, and exposure to administrative fines and product recalls.
How much does GMP preparation cost?
The law does not fix a preparation cost; the plant pays only the prescribed appraisal fee for the state procedure. The real cost sits in premises, equipment, quality systems and consulting, and depends on plant scale and the gap to GMP standards, so a gap assessment should precede any budget.
This article has been quality-reviewed by the FLAW AI Legal Council