PIC/S - Pharmaceutical Inspection Co-operation Scheme

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) became operational in November 1995 and provides an active and constructive co-operation in the field of GMP (Good Manufacturing Practice) for drugs. Its purpose is to :

• facilitate the networking and cooperation between participating Regulatory Authorities
• maintain mutual confidence,
• promote quality assurance of inspections
• exchange information and experience in the field of GMP and related areas
• coordinate mutual training of GMP inspectors
• improve and harmonize technical standards and procedures related to GMP with a view to contributing to global harmonization.

Canada, represented by the Health Products and Food Branch Inspectorate (Inspectorate), has been a member of PIC/S since January 1999. One additional advantage for the Inspectorate to be in the PIC/S is the acceptance of inspection report, issued by the Regulatory Authorities that are also part of the scheme, for the purpose of listing foreign sites on the Establishment licence of the Importer.

For more information related to PIC/S, please consult their website at: Pharmaceutical Inspection Co-operation Scheme

Guidance on Parametric Release - Pharmaceutical Inspection Co-operation Scheme (PIC/S)