Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme

The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) are two international instruments between countries and pharmaceutical inspection authorities. The PIC/S is meant as an instrument to improve co-operation in the field of Good Manufacturing Practices between regulatory authorities and the pharmaceutical industry.

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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.

See also

• GxP
• Good Automated Manufacturing Practice (GAMP)
• Corrective and Preventative Action (CAPA)
• Validation (drug manufacture)
• European Medicines Agency (EMEA)
• Food and Drug Administration (FDA)
• Ministry of Health, Labour and Welfare (Japan)
• European Federation of Pharmaceutical Industries and Associations (EFPIA)
• Pharmaceutical Research and Manufacturers of America (PhRMA)
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