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7335531 
Book/Book Chapter 
Standards of Good Practice for the Conduct of Regulated Nonclinical Safety Studies 
Gittelson, PL 
2010 
Elsevier Inc. 
Comprehensive Toxicology, Second Edition 
3 
87-96 
English 
The Good Laboratory Practice (GLP) regulations were first promulgated in 1976 by the U.S. Food and Drug Administration (FDA) in response to evidence of scientific misconduct in the performance of laboratory safety/toxicology studies submitted in support of new drug approvals. They have since been adopted as a worldwide standard for conducting nonclinical laboratory studies intended to meet regulatory requirements for approval of new medical and chemical products. The GLPs impose requirements both on testing facilities in general and on each study in particular. They prescribe an organizational framework and management structure for testing facilities, and dictate that each testing facility develops standard operating procedures (SOPs) and study protocols to control critical functions and demonstrate that they operate in compliance with verifiable standards for study conduct, quality assurance, and documentation. The GLPs also provide for a program of regulatory inspections and sanctions to ensure that these standards are being met. © 2010 Copyright 2010 Elsevier Ltd All rights reserved.