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OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring - PharmaFacts
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OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring

Guidances - OECD Guidances

The 1981 Council Decision on Mutual Acceptance of Data [C(81)30(Final)], of which the OECD Principles of Good Laboratory Practice1 are an integral part, includes an instruction for OECD to undertake activities "to facilitate internationally-harmonized approaches to assuring compliance" with the GLP Principles. Consequently, in order to promote the  implementation of comparable compliance monitoring procedures, and international acceptance, among Member countries the Council adopted in 1983 the Recommendation concerning the Mutual Recognition of Compliance with Good Laboratory Practice [C(83)95(Final)], which set out basic characteristics of the procedures for monitoring compliance. A Working Group on Mutual Recognition of Compliance with GLP was established in 1985, under the chairmanship of Professor V. Silano (Italy), to facilitate the practical implementation of the Council acts on GLP, develop common approaches to the technical and administrative problems related to GLP compliance and its monitoring, and develop arrangements for the mutual recognition of compliance monitoring procedures. The following countries and organisations participated in the Working Group: Australia, Belgium, Canada, Denmark, the Federal  Republic of Germany, Finland, France, Italy, Japan, Norway, the Netherlands, Portugal, Spain, Sweden, Switzerland, the United Kingdom, the United States, the Commission of the European Communities, the International Organization for Standardization, the Pharmaceuticals Inspections Convention, and the World Health Organization.