Good Laboratory Practice for Nonclinical Laboratory Studies: A Review

| 01 July 2008

The US Food and Drug Administration promulgated the Good Laboratory Practice regulations for nonclinical laboratory studies in 1979, following the discovery that data in studies submitted in support of an application had been falsified. GLPs are intended to ensure the quality and integrity of safety data, allow experiments to be reconstructed accurately and support the approval of new products. They are codified in 21 CFR Part 58, which is broken down into subparts A through K, with subparts H and I reserved. Each subpart provides a description and clarification of the regulation being reviewed.

 

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