Testing evidence for GMP inspections under PIC/S guidance
GMP inspectors ask for evidence that cleanrooms, HVAC and utility systems have been tested against the specified criteria. QV TEST carries out these tests and prepares the reports for your QA team to use during the inspection. We are not a GMP certification body. GMP certificates in Thailand are issued by the Thai Food and Drug Administration (Thai FDA).
Key facts
Thailand and PIC/S
The Thai FDA has been a PIC/S member since 2016
Main reference guidance
PIC/S GMP Guide PE 009-17 (Thai MOPH notification B.E. 2569), Annex 1 (sterile products), Annex 15 (Qualification & Validation)
Annex 1 in Thailand
Thai MOPH GMP notification B.E. 2569 (2026) adopts PIC/S PE 009-17; Annex 1 may follow PE 009-16 until 31 December 2029
QV TEST's role
We test, measure and issue reports as evidence. We do not issue GMP certificates.
Evidence inspectors usually ask for, and related services
| Inspection topic | Evidence needed | Service / standard |
|---|---|---|
| Cleanroom classification | Particle count report, ISO Class / GMP Grade | Cleanroom testing · ISO 14644-1, Annex 1 |
| HVAC system | DQ IQ OQ PQ reports, air velocity, air changes, pressure differentials | DQ IQ OQ PQ · Annex 15 |
| Storage of medicines and materials | Temperature mapping reports for stores and refrigerators | Temperature mapping · WHO TRS 961 Annex 9 Supplement 8 |
| Compressed air in contact with product | Compressed air quality report against the specified class | CDA · ISO 8573-1 |
| Area decontamination | Decontamination records and BI/CI results | Decontamination |
Evidence of the tester's competence
GMP inspectors often ask to see the qualifications of the testing provider
How we work
1
Review with your QA team the areas and systems that need evidence
2
Check whether existing reports are still within their validity period and where the gaps are
3
Plan and test only what is missing or expired
4
Deliver reports in a format inspectors can read straight away
Frequently asked questions
Can QV TEST issue a GMP certificate?
No. GMP certificates are issued by the Thai FDA. We test and issue reports that serve as supporting evidence for the inspection.
What is PIC/S?
PIC/S (Pharmaceutical Inspection Co-operation Scheme) is a co-operation between the GMP inspectorates of many countries, so they use the same GMP standards and inspection methods.
What did Annex 1 in PE 009-17 change for cleanrooms?
It places emphasis on a contamination control strategy (CCS) and sets maximum requalification intervals of 6 months for Grade A and B and 12 months for Grade C and D (clause 4.32). In Thailand, the MOPH GMP notification B.E. 2569 allows Annex 1 to follow PE 009-16 until 31 December 2029.
Talk to us before your inspection
GMP inspection already scheduled? Send us your list of areas and the inspection date and we will help you find the gaps in your evidence
