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GMP inspection readiness: the findings we see most often
Thai FDA and PIC/S GMP inspections turn up the same handful of findings again and again. Knowing them in advance beats fixing them afterwards.
The findings we see most
Documentation and records
Incomplete batch records, back-dated signatures, and corrections without an auditable trail are by far the most common findings.
Change control
Process or material changes made without a systematic impact assessment and formal approval.
Calibration and maintenance
Calibration plans that do not cover all critical instruments, or plans with no evidence of execution.
Complaint handling and recall
No clearly written procedure, or a procedure that has never been rehearsed.
How to prepare
- Run a readiness assessment against current requirements
- Hold a mock audit with an independent assessor
- Build a CAPA plan with named owners and deadlines
- Track remediation through to genuine closure
- Prepare the team and the document room for inspection day
We provide consultancy across all five steps, including onsite support on the day.
- GMP
- PIC/S
- CAPA
