1What PIC/S is.
The Pharmaceutical Inspection Co-operation Scheme is “a non-binding, informal co-operative arrangement between Regulatory Authorities in the field of Good Manufacturing Practice”, open to any authority with a comparable GMP inspection system. It has 57 Participating Authorities from Europe, Africa, the Americas, Asia and Australasia.¹ Its mission is “to lead the international development, implementation and maintenance of harmonised GMP standards and quality systems of inspectorates”: it writes GMP guides and guidance, trains inspectors, and assesses and reassesses member inspectorates.¹
It grew out of the Pharmaceutical Inspection Convention, founded by EFTA in October 1970 as the Convention for the Mutual Recognition of Inspections in Respect of the Manufacture of Pharmaceutical Products. In the early 1990s an incompatibility between the Convention and European law meant no new countries could join, so the PIC Scheme was formed on 2 November 1995. The Convention and the Scheme run in parallel and together are called PIC/S.²
Participating Authorities include the US FDA (since January 2011), the UK’s MHRA, Health Canada, Australia’s TGA, Japan, Singapore, Brazil’s ANVISA, Saudi Arabia’s SFDA and the inspectorates of most EU Member States.³
2What membership does and doesn’t mean.
PIC/S is a non-binding arrangement, not a mutual recognition agreement. It says it “is not a trade agreement”, and members share inspection reports voluntarily. Membership can make other agreements easier to reach, such as the Australia–Canada and EU–Switzerland MRAs, and some authorities outside PIC/S accept GMP certificates from Participating Authorities.⁴ Members also take part in the PIC/S Rapid Alert and Recall System for quality defects in distributed batches.⁴
Joining is a two-stage process: a voluntary pre-accession assessment, with a gap analysis by an auditor, and then the accession procedure itself.⁵
3How the PIC/S GMP Guide relates to EU GMP.
The PIC/S GMP Guide is the scheme’s “main instrument for harmonisation”. It began as the PIC Basic Standards of 1972, derived from the WHO GMP Guide. In 1989 the EU adopted its own GMP Guide, equivalent in its requirements, and since then the two have been developed in parallel: “whenever a change has been made to one, the other has been amended so that both Guides are practically identical”.⁶⁷ A co-operation agreement between PIC/S and EMA requires the two guides to be kept harmonised.⁸ WHO publishes its own GMP main principles separately, in Annex 2 of Technical Report Series 986 (2014).⁹
The PIC/S Guide lists the differences itself.⁷
| Point | EU GMP guide | PIC/S GMP Guide |
|---|---|---|
| Person who certifies batches | Qualified Person | Authorised person |
| Legal references | EU directives and MRAs | Removed |
| Pharmacopoeia | European Pharmacopoeia | “European or other relevant Pharmacopoeia” |
| Product definition | Medicinal product, as in EU law | The PIC Convention’s definition of pharmaceutical product, retained |
| Structure | Parts I to IV, annexes and glossary¹⁰ | Part I, Part II, annexes and glossary |
Part II of both guides, for active substances, is built on ICH Q7A. PIC/S drafted the first version before handing it to ICH, adopted the finished guide in 2001 and decided in 2006 to make it Part II.⁷ Changes still land together. The revised Annex 19 on reference and retention samples took effect on 24 September 2026 in the EU and in PIC/S Guide PE 009-18, and PIC/S invited its non-EEA authorities to transpose it into their own GMP guides.⁸⁷
The guide takes legal effect only through each authority’s own rules. Its introduction says national administrative measures should apply these standards, and any new or amended national GMP regulations “should at least meet their level”.⁷ So for a US site, the binding drug GMP requirements are still 21 CFR Parts 210 and 211, though FDA is a Participating Authority.¹¹³
4Other PIC/S guidance people use.
| Document | Subject | Date |
|---|---|---|
| PI 041-1 | Good practices for data management and integrity in regulated GMP/GDP environments | 1 July 2021¹² |
| PI 006-4 | Recommendations on qualification and validation, replacing PI 006-3 | In force 1 October 2026⁸ |
| PI 058-1 | Interpretation of the main changes in the 2022 Annex 1 on sterile products, adopted by PIC/S, EMA and WHO | In force 28 October 2026⁸ |
PIC/S also works on the EU texts directly. The European Commission’s 2025 drafts of a revised Chapter 4, a revised Annex 11 and a new Annex 22 on artificial intelligence were written by EMA’s GMP/GDP Inspectors Working Group in cooperation with PIC/S.¹³
5How it runs in Seal.
In Seal, quality management covers deviations, CAPA, change control, documents, training, audits, suppliers, complaints and risk, with evidence linked to the batch, step and version it concerns, and workflows configured for the product and jurisdiction.
Every record keeps its audit history and electronic signatures, with controls to support EU GMP Annex 11 and 21 CFR Part 11, as Regulatory and validation sets out. No software alone makes an operation compliant: your quality system, configuration, procedures and training remain part of the assessment.
References
- 1Introduction, PIC/S. https:/
/ picscheme. org/ en/ about (read 6 November 2026) - 2History, PIC/S. https:/
/ picscheme. org/ en/ history (read 6 November 2026) - 3Members: list of PIC/S Participating Authorities, PIC/S. https:/
/ picscheme. org/ en/ members (read 6 November 2026) - 4Benefits, PIC/S. https:/
/ picscheme. org/ en/ benefits (read 6 November 2026) - 5Accession procedure, PIC/S. https:/
/ picscheme. org/ en/ accession- procedure (read 6 November 2026) - 6Publications: GMP, PIC/S. https:/
/ picscheme. org/ en/ publications?tri=gmp (read 6 November 2026) - 7PIC/S Guide to Good Manufacturing Practice for Medicinal Products, PE 009-18 (Introduction), PIC/S, 24 September 2026. https:/
/ picscheme. org/ docview/ 11331 (read 6 November 2026) - 8News, PIC/S, July to October 2026. https:/
/ picscheme. org/ en/ news (read 6 November 2026) - 9WHO good manufacturing practices for pharmaceutical products: main principles, TRS 986 Annex 2, World Health Organization, 2014. https:/
/ www. who. int/ publications/ m/ item/ trs986- annex2 (read 6 November 2026) - 10EudraLex Volume 4, Good Manufacturing Practice guidelines, European Commission. https:/
/ health. ec. europa. eu/ medicinal- products/ eudralex/ eudralex- volume- 4_ en (read 6 November 2026) - 1121 CFR 210.1, Status of current good manufacturing practice regulations, eCFR, current to 4 November 2026. https:/
/ www. ecfr. gov/ current/ title- 21/ chapter- I/ subchapter- C/ part- 210/ section- 210. 1 (read 6 November 2026) - 12PI 041-1, Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments, PIC/S, 1 July 2021. https:/
/ picscheme. org/ docview/ 4234 (read 6 November 2026) - 13Stakeholders’ consultation on EudraLex Volume 4: Chapter 4, Annex 11 and new Annex 22, European Commission, 7 July to 7 October 2025. https:/
/ health. ec. europa. eu/ consultations/ stakeholders- consultation- eudralex- volume- 4- good- manufacturing- practice- guidelines- chapter- 4- annex_ en (read 6 November 2026)
AQuestions and answers
Is PIC/S a regulator?
No. It is a non-binding, informal co-operative arrangement between regulatory authorities. Licences, inspections and GMP certificates come from the Participating Authorities themselves; PIC/S develops the shared guide, trains inspectors and assesses its members’ inspectorates.
Is the FDA a member of PIC/S?
Yes. FDA joined the PIC Scheme in January 2011. Its binding drug GMP requirements are still the US regulations in 21 CFR Parts 210 and 211, so a US site follows those rather than the PIC/S Guide as such.
Does PIC/S membership mean authorities accept each other’s inspections?
Not automatically. PIC/S is not a trade agreement, and members share inspection reports voluntarily. Formal reliance on another authority’s inspections comes from mutual recognition agreements, which PIC/S membership can make easier to negotiate.
How is the PIC/S GMP Guide related to WHO GMP?
The PIC/S Guide began in 1972 as the PIC Basic Standards, derived from the WHO GMP Guide, and was developed further for stricter requirements and new areas such as biologicals. WHO still publishes its own GMP main principles separately.