The UGA Quality Assurance Unit provides information and training for researchers about federal Good Laboratory Practices (GLP), the recognized rules governing the conduct of non-clinical safety studies that ensure the quality, integrity and reliability of the study data.
Good Laboratory Practices
The Good Laboratory Practice standards (GLPs) are federal regulations promulgated in the United States by both the Food and Drug Administration in 21 CFR Part 58 and the Environmental Protection Agency both for FIFRA in 40 CFR Part 160 and for TSCA in 40 CFR Part 792.
The Good Laboratory Practice regulations describe the minimal standards for conducting nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for products regulated by FDA or EPA such as animal food additives, human and animal drugs, medical devices for human use, biological products, electronic products, or pesticide products.
The regulations do not pertain to studies utilizing human subjects or clinical studies for which the current Good Clinical Practice (cGCP) standards would apply. Nor do the GLPs pertain to basic exploratory studies carried out to determine whether a test article has any potential utility or, for FDA studies only, to determine physical or chemical characteristics of a test article.