PIC/S is the abbreviation and logo used to describe both the Pharmaceutical Inspection Convention (PIC) and the Pharmaceutical Inspection Co-operation Scheme (PIC Scheme) operating together in parallel.
The PIC Scheme commenced operating on 2 November 1995 in conjunction with PIC which had already been operating since 1970 (see "Background on PIC"). Thus PIC/S became operational in November 1995.
The need to form the PIC Scheme became necessary when it was realised that an incompatibility between PIC and European law did not permit individual EU countries that were members of PIC to sign agreements with other countries seeking to join PIC. Only the European Commission was permitted to sign agreements with countries outside Europe, and the Commission itself was not a member of PIC.
Therefore, a less formal and more flexible cooperation scheme was developed to continue and enhance the work of PIC. Instead of being a legal treaty between countries (ie. like PIC), the PIC Scheme is a cooperative arrangement between Health authorities.
PIC and the PIC Scheme, operating together as PIC/S, provide an active and constructive co-operation in the field of GMP (Good Manufacturing Practice). The purpose of PIC/S is to facilitate the networking between participating authorities and the maintenance of mutual confidence, the exchange of information and experience in the field of GMP and related areas, and the mutual training of GMP inspectors.
The main differences between the PIC Scheme and PIC are :
|An informal arrangement||A formal treaty|
|Has no legal status||Has legal status|
|Between Health authorities||Between countries|
|Exchange of information||Mutual recognition of inspections|