Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme

The PIC (Pharmaceutical Inspection Convention) was founded in October 1970 by the European Free Trade Association (EFTA), under the title of the Convention for the Mutual Recognition of Inspections in Respect of the Manufacture of Pharmaceutical Products. The initial members comprised the 10 member countries of EFTA at that time. In the early 1990s it was realized that because of an incompatibility between the Convention and European law, it was not possible for new countries to be admitted as members of PIC. European law did not permit individual EU countries that were members of PIC to sign agreements with other countries seeking to join PIC. As a consequence the Pharmaceutical Inspection Co-operation Scheme was formed on 2 November 1995. The Pharmaceutical Inspection Co-operation Scheme is an informal agreement between health authorities instead of a formal treaty between countries. PIC and the PIC Scheme, which operate together in parallel, are jointly referred to as PIC/S. PIC/S became operational in November 1995. ==Purpose==

PIC/S has a number of provisions intended to establish the following: • Mutual recognition of inspection between member countries, so that an inspection carried out by officials of one member country will be recognized as valid by other members. • Equivalent principles of inspection methodology, so that it is understood that inspectors in each member country will be following the same best practices when carrying out inspections. • Mechanisms for the training of inspectors. • Harmonization of written standards of Good Manufacturing Practices. • Lines of communication between member country inspectors/inspectorates. == Members ==

The following are the state members of PIC/S as of October 2021: == See also ==