Federal Good Laboratory Practices regulation

FDA (Food and Drug Administration). (1987a). Good Laboratory Practice Regulations Final Rule. 21 CFR Part 58, Federal Register, September 4, 1987. 

U.S. Food and Drug Administration (FDA), Nonclinical Laboratory Studies. Proposed Regulations for Good Laboratory Practice Regulations. Proposed Rule, Federal Register, 1976 41, 51206-51228. 

This study was conducted in accordance with FDA Good Laboratory Practice Regulations (FDA, Tide 21 CFR Part 58, Federal Register, 22 December 1978 and subsequent Amendments 11 April 1980 and 4 September 1987) except that data concerning the identity, purity and stability of the test material and stability of the test material/carrier mixture were generated within a GMP environment. 

The enclosed report for Study accurately describes nethods and procedure useoininertudy and accurately reflects the raw data obtained. The study was conducted In compliance with Good Laboratory Practice for Noncllnical Laboratory Studies as described in the Federal Register 21 CFR 58. There were no differences, with the exception of a few instances of incorrect data entries/corrections, discovered between practices used in conducting the study and those required by Good Laboratory Practice regulations. 

Food and Drug Administration Non-Clinical Laboratory Studies, Good Laboratory Practice Regulations. U.S. Federal Register, vol. 41, No. 225, November 19, 1976. pp. 51206-51226 (Proposed Regulations) and vol. 43. No. 247, December 22. 1978, pp. 59986- 60020. (Final Rule). 

Because of the success of the CGMP laws, a new line of thought was developed that involved the subject of good laboratory practices. On December 22, 1978, the regulations entitled Non-clinical Laboratory Studies were issued in the Federal Register [21]. These regulations, which became known as Good Laboratory Practice, are involved in the evaluation of nonclinical laboratory studies. 

Final Rule for Good Laboratory Practice Standards under the Federal Insecticide, Fungicide and Rodenticide Act, Code of Federal Regulations, Title 40, Part 160. 

GLP stands for good laboratory practices. These are federal regulations governing FDA- and EPA-affiliated laboratories and pertain to proper procedures in the laboratory to ensure that results are obtained in as trustworthy a manner as possible. SOP stands for standard operating procedure. These are step-by-step written procedures that are specially approved by laboratory directors for carrying out certain specific tasks. 

Good Laboratory Practice (GLP) regulations under the Federal Insecticide, Fungicide, and Rodenti-cide Act (FIFRA) apply only to health effects studies. The Toxic Substances Control Act (TSCA)... 

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