Pharmaceutical Inspection Co-operation Scheme
Harmonizes GMP inspection standards (PE 009) across 50+ participating authorities.
What this page does not claim
SPEQ curates and cross-references these bodies. It is not affiliated with, accredited by, or endorsed by any of them, and a count of decoded standards is a measure of SPEQ’s coverage, not of a body’s importance.
WHAT PIC/S COVERS
The Pharmaceutical Inspection Co-operation Scheme is a cooperative arrangement between GMP inspectorates — not a regulator and not a treaty organisation. Its purpose is harmonising inspection standards and building mutual confidence between authorities so that inspection outcomes can be relied upon across borders.
WHAT PIC/S PUBLISHES
- 01PE 009 — the PIC/S Guide to Good Manufacturing Practice, mirroring the EU GMP Guide
- 02PI 041-1 — Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments
- 03Aide-mémoires and guidance documents for inspectors
- 04PE 011 GDP guide and other inspection-related instruments
- 05Training materials and joint-inspection programme outputs
HOW ITS REQUIREMENTS BITE
PIC/S issues no binding requirements itself. Participating authorities adopt its GMP guide into their own frameworks — Australia adopts PE 009 directly as its national code, and many others align to it — and the scheme supports joint inspections, inspector training, and assessment of authorities applying to join. Its practical value is that a PIC/S-standard inspection means something similar wherever it is performed.
What practitioners get wrong
- PI 041-1 is written for inspectorates — which makes it the clearest public view of how data integrity is actually assessed.
- PE 009 closely mirrors the EU GMP Guide, so EU-compliant sites are substantially PIC/S-compliant.
- PIC/S membership is the practical basis for many reliance and recognition arrangements between regulators.
- Check which PE 009 version a given authority has adopted — adoption lags publication.
What an inspection under this authority actually probes
WHERE IT SITS INTERNATIONALLY
The register of participating authorities spans over fifty jurisdictions, including the FDA, EU member states, the MHRA, Health Canada, the TGA, Japan (MHLW and PMDA, counted as one authority), Brazil (ANVISA) and Mexico (COFEPRIS) — which makes PIC/S the closest thing to a global GMP inspection standard. Membership is by inspectorate, so check the register rather than assuming a country is in: Colombia, for one, is not.
PIC/S STANDARDS SPEQ DECODES · 4
DISCIPLINES IN PIC/S’S REMIT
PIC/S: frequently asked questions
Reference answers on Pharmaceutical Inspection Co-operation Scheme’s mandate, what it publishes, and how its requirements acquire force.
What is a PIC/S member?
PIC/S — the Pharmaceutical Inspection Co-operation Scheme — is a cooperative arrangement between GMP inspectorates, not a regulator or treaty organisation. A participating authority has been assessed against its standards; PIC/S supports joint inspections, inspector training, and mutual confidence so inspection outcomes can be relied on across borders.
What is PE 009?
PE 009 is the PIC/S Guide to Good Manufacturing Practice, which closely mirrors the EU GMP Guide — so EU-compliant sites are substantially PIC/S-compliant. Participating authorities adopt it into their own frameworks; Australia adopts it directly as its national code. Check which version an authority has adopted.
Does PIC/S issue binding requirements?
No. PIC/S issues no binding requirements itself; its documents, including PI 041-1 on data integrity, take force through each authority’s adoption. With over fifty participating authorities including FDA, EU member states, MHRA, Health Canada, TGA, and PMDA, it is the closest thing to a global GMP inspection standard.