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Good Laboratory Practice

OECD Principles and Guidance for Compliance Monitoring

image of Good Laboratory Practice

This publication unites all of the OECD documents related to Good Laboratory Practice and compliance monitoring, and, in the Annex, reproduces the three OECD Council Decisions related to the Mutual Acceptance of Data in the Assessment of Chemicals. It includes the international standards for quality of non-clinical environmental, health and safety data on chemicals and chemical products in a regulatory context—the OECD Principles of Good Laboratory Practice—and supporting Consensus and Advisory Documents on their interpretation and application. The OECD guidance documents for governments on monitoring compliance with the Good Laboratory Practice Principles are also included. This publication thus presents the state of the art on Good Laboratory Practice and compliance monitoring.

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Guidance for GLP Monitoring Authorities

The 1981 Council Decision on Mutual Acceptance of Data [C(81)30(Final)], of which the OECD Principles of Good Laboratory Practice are an integral part, includes an instruction for OECD to undertake activities “to facilitate internationally-harmonised 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.

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