Good Laboratory Practices Guide

This Guide examines the GLP regulations of the United States and other countries in detail and provides guidelines for compliance, using as a basis the GLP requirements published in the US Code of Federal Regulations, Title 21, Part 58, 2008 Edition. These regulations are intended to assure the quality and integrity of any safety or efficacy data, especially animal testing data, submitted in support of an application to move into cliniReport covercal trials or for approval to market the new drug. Following this Guide’s recommendations, scientists and managers responsible for academic research, commercial start-up research and development operations, or established industrial laboratories can understand the impact of GLP requirements on their work and assist them in achieving full compliance simply and inexpensively. The recommendations presented in this Guide have been distilled from a large body of information and opinion. The most recent guidelines issued by the FDA and other regulatory authorities to industry and to inspection staff have been referenced. Opinion and advice collected from other regulatory consultants, including ex-FDA personnel, has been reviewed and taken into consideration. A set of forms derived directly from the 21CFR 58 regulations is provided as an appendix. They can be copied directly from the book as needed. Each requirement is covered to ensure that every compliance factor is reviewed.

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