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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Advisory Documents of the Working Group on GLP

In the framework of the Revision of the OECD Principles on Good Laboratory Practice, the Expert Group was not able to reach consensus on whether and how to deal with the role and responsibilities of the sponsor of chemical safety studies in the Principles. The revised Principles of GLP contain several explicit references to the sponsor, and the issue is implicit in several other principles. However, there was no agreement on the need for and content of a separate section in the Principles on this matter.

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