Standards & Regulations
Thailand’s 2026 GMP Notification: PIC/S PE 009-17 and When the New Annex 1 Applies
What the notification sets out
| Topic | Key point | Clause |
|---|---|---|
| Dates | Signed 1 July 2026, published in the Royal Gazette on 3 July 2026 (Vol. 143, Special Part 164 Ng). It takes effect after 30 days from publication in the Royal Gazette. | 1 |
| Repealed notifications | The B.E. 2559 (2016) notification on traditional drug manufacturing and the B.E. 2567 (2024) notification on modern drug manufacturing | 2 |
| Standard adopted | PIC/S Guide to Good Manufacturing Practice for Medicinal Products Part I, Part II and Annexes, PE 009-17 (Appendix 1 of the notification) | 3 |
| Exceptions | Annex 1 follows PE 009-16 until 31 December 2029; Annex 6 (manufacture of medicinal gases) is excluded | 3 (1)–(2) |
| Veterinary autogenous vaccines | Follow the EU Adapted GMP principles for inactivated veterinary autogenous vaccines (Appendix 2) | 4 |
Which Annex 1 applies when
| Period | Annex 1 under the notification |
|---|---|
| From the effective date to 31 Dec 2029 | Annex 1 of PIC/S PE 009-16 |
| After 31 Dec 2029 | Annex 1 of PIC/S PE 009-17 (dated 25 August 2023, attached to the notification) |
The rest of the GMP Guide (Part I, Part II and the other Annexes except Annex 6) follows PE 009-17 from the effective date. Sterile manufacturers therefore have a transition period for Annex 1, but cleanrooms, qualification records and monitoring programmes should be ready before the end of 2029.
What changed in the particle limits
Comparison of maximum particle limits for cleanroom classification (particles per m³)
| Grade | ≥ 0.5 µm at rest / in operation (both editions) | ≥ 5 µm, PE 009-16 | ≥ 5 µm, PE 009-17 (Table 1) |
|---|---|---|---|
| A | 3,520 / 3,520 | 20 / 20 | Not specified (a) / Not specified (a) |
| B | 3,520 / 352,000 | 29 / 2,900 | Not specified (a) / 2,930 |
| C | 352,000 / 3,520,000 | 2,900 / 29,000 | 2,930 / 29,300 |
| D | 3,520,000 / not defined | 29,000 / not defined | 29,300 / not predetermined (b) |
(a) PE 009-17 states that classification including 5 µm particles may be considered where indicated by the CCS or historical trends. (b) For Grade D in operation, the manufacturer sets limits based on risk assessment and routine data. For monitoring, Table 5 of PE 009-17 sets the ≥ 5 µm limit at 29 for Grade A and for Grade B at rest.
PE 009-16 clause 5 states that Grade A corresponds to ISO 4.8, driven by the ≥ 5.0 µm limit of 20 particles per m³. In PE 009-17, Grade A classification is based on the ≥ 0.5 µm limit of 3,520.
Cleanroom qualification under PE 009-17
PE 009-17 Annex 1 clause 4.25 lists the tests for qualifying cleanrooms and clean air equipment (where relevant to the design or operation): installed filter leakage and integrity, airflow volume and velocity, air pressure difference, airflow direction and visualisation, airborne and surface microbial contamination, temperature, relative humidity, recovery, and containment leak testing.
| Topic | What PE 009-17 Annex 1 requires | Clause |
|---|---|---|
| States for classification | Both at rest and in operation; at-rest limits must be met after a clean-up period (guidance value under 20 minutes) | 4.29 |
| Unidirectional air speed | Guidance value 0.36–0.54 m/s at the working position, unless scientifically justified in the CCS | 4.30 |
| Microbial limits during qualification (Table 2) | Grade A no growth · B: air 10 CFU/m³, settle plates 5 CFU/4 h, contact plates 5 CFU · C: 100 / 50 / 25 · D: 200 / 100 / 50 | 4.31 |
| Minimum requalification | Particle classification, final filter integrity, airflow volume, pressure difference and air velocity (for Grades B, C and D per the CCS risk assessment; in non-unidirectional areas, recovery testing replaces velocity testing) | 4.32 |
| Maximum requalification interval | Grade A and B: 6 months · Grade C and D: 12 months, plus after remedial action or significant change | 4.32 |
| Sampling locations | Minimum per ISO 14644-1, with additional locations considered in Grade A and B areas such as the point of fill | 4.28 |
What to prepare now
- Check that existing classification reports include ≥ 5 µm and microbial results for both at rest and in operation.
- Confirm requalification intervals do not exceed 6 months for Grade A and B and 12 months for Grade C and D.
- Define and record the clean-up period for each room during qualification.
- Review the justification for unidirectional air speeds and recovery testing in non-unidirectional areas.
- Link test results to the contamination control strategy (CCS) under clause 2.3.
FAQ
Which Annex 1 applies now?
Under clause 3 (1) of the B.E. 2569 notification, Annex 1 of PE 009-16 may be used until 31 December 2029; after that, PE 009-17 applies.
Have the ≥ 0.5 µm limits for Grades A–D changed?
No. Both PE 009-16 and PE 009-17 use 3,520 / 352,000 / 3,520,000 particles per m³ for the same grades and states. The change is in the ≥ 5 µm limits.
How often must cleanrooms be requalified?
PE 009-17 Annex 1 clause 4.32 sets maximum intervals of 6 months for Grade A and B and 12 months for Grade C and D.
References
- Notification of the Ministry of Public Health on rules and methods for drug manufacturing under the drug law, B.E. 2569 (Royal Gazette Vol. 143, Special Part 164 Ng, 3 July 2026), clauses 1–4
- PIC/S Guide to Good Manufacturing Practice for Medicinal Products, PE 009-17 (25 August 2023), Annex 1: Manufacture of sterile medicinal products, clauses 2.3, 4.25–4.32, Tables 1, 2 and 5
- PIC/S Guide to Good Manufacturing Practice for Medicinal Products, PE 009-16 (1 February 2022), Annex 1, clauses 4–5
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