Guide to Good Manufacturing Practice for Medicinal Products
The PIC/S GMP Guide is harmonised with EU GMP and serves as the reference GMP standard for all PIC/S participating authorities. Forms the basis for mutual recognition agreements between regulatory authorities globally.
Pharmaceutical manufacturers in all 57 PIC/S member countries. Practically equivalent to EU GMP — used when manufacturing for markets outside the US and EU.
- 01All EU GMP requirements are adopted by reference through PIC/S harmonisation
- 02Additional national annexes may apply depending on the specific PIC/S member country
- 03Inspection reports shared between PIC/S members — single inspection accepted by multiple authorities
Updated July 2023. Incorporates EU GMP Annex 1 (2022) and latest EU GMP revisions.
PIC/S PE 009-16: frequently asked questions
Quick answers to common questions about PIC/S PE 009-16.
What is PIC/S PE 009-16?
PIC/S PE 009-16 — Guide to Good Manufacturing Practice for Medicinal Products — is a guidance issued by the Pharmaceutical Inspection Co-operation Scheme. The PIC/S GMP Guide is harmonised with EU GMP and serves as the reference GMP standard for all PIC/S participating authorities. Forms the basis for mutual recognition agreements between regulatory authorities globally.
Who does PIC/S PE 009-16 apply to?
Pharmaceutical manufacturers in all 57 PIC/S member countries. Practically equivalent to EU GMP — used when manufacturing for markets outside the US and EU.
What are the key requirements of PIC/S PE 009-16?
PIC/S PE 009-16 requires, among other things: All EU GMP requirements are adopted by reference through PIC/S harmonisation; Additional national annexes may apply depending on the specific PIC/S member country; Inspection reports shared between PIC/S members — single inspection accepted by multiple authorities.
When was PIC/S PE 009-16 last updated?
The current version of PIC/S PE 009-16 dates from August 2022. Updated July 2023. Incorporates EU GMP Annex 1 (2022) and latest EU GMP revisions.
Live openFDA recalls SPEQ maps to this standard’s topics — a SPEQ interpretation, not an FDA classification.
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.
Track the standards that move
When PIC/S PE 009-16 — or any GxP requirement — is revised, recalled against, or clarified by new guidance, the Weekly GxP Briefing surfaces it. Free, one email a week.