Pharmaceutical Inspection Co-operation Scheme
Harmonizes GMP inspection standards (PE 009) across 50+ participating authorities.
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.
WHERE IT SITS INTERNATIONALLY
With over fifty participating authorities including FDA, EU member states, MHRA, Health Canada, TGA, PMDA, ANVISA, ANMAT and INVIMA, PIC/S is the closest thing to a global GMP inspection standard.
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 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
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.
PIC/S STANDARDS SPEQ DECODES · 2
DISCIPLINES IN PIC/S’S REMIT
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