PIC/S
Pharmaceutical Inspection Co-operation Scheme
What a definition is not
A definition is SPEQ’s plain-language decode of how a term is used in practice, cited to the documents that define it. It is a practitioner reference, not legal or regulatory advice, it does not replace the definition in the source, and where a regulator’s wording differs the regulator’s wording governs.
PIC/S is a non-binding, informal co-operative arrangement between regulatory authorities in the field of GMP for medicinal products, aimed at harmonizing inspection procedures and GMP standards and networking between inspectorates. It maintains a widely referenced GMP guide (aligned closely with EU GMP) and issues guidance and training for inspectors. Membership is by inspectorate rather than by country, and provides a route to mutual confidence in GMP inspections without a formal treaty.
PIC/S is deliberately not a legislative body: its guides and annexes acquire force only when a member authority adopts them into its own framework. Its value is convergence — many inspectorates worldwide operate to a substantially common GMP standard because they follow the PIC/S guide.
The PIC/S GMP Guide and the EU GMP Guide are maintained in close alignment, which is why practitioners often treat the two as effectively parallel documents.
- —Informal co-operation among GMP inspectorates — not a treaty body
- —Maintains a widely adopted GMP guide aligned with EU GMP
- —Membership is by authority/inspectorate, not by state
- —Drives convergence and mutual confidence in inspections
PIC/S Guide to Good Manufacturing Practice for Medicinal Products (PE 009).
Frequently asked questions
What does PIC/S stand for?
PIC/S stands for Pharmaceutical Inspection Co-operation Scheme.
What is PIC/S?
PIC/S is a non-binding, informal co-operative arrangement between regulatory authorities in the field of GMP for medicinal products, aimed at harmonizing inspection procedures and GMP standards and networking between inspectorates. It maintains a widely referenced GMP guide (aligned closely with EU GMP) and issues guidance and training for inspectors. Membership is by inspectorate rather than by country, and provides a route to mutual confidence in GMP inspections without a formal treaty.
Which regulations cover PIC/S?
PIC/S Guide to Good Manufacturing Practice for Medicinal Products (PE 009).