The various acts enforced by FDA require an adequate showing of product safety prior to introduction into the marketplace. In order to ensure adequate quality control for these studies and to provide an adequate degree of consumer protection, FDA promulgated the Good Laboratory Practice (GLP) regulations (21 CFR Part 58) in 1978. The regulations specify minimum standards for the proper conduct of safety testing and contain sections on facilities, personnel, equipment, standard operating procedures, test and control articles, quality assurance, protocol and conduct of a safety study, records and reports, and laboratory disqualification.
The GLP Booklet App presents the regulations for Good Laboratory Practice in a user-friendly e-format. The users can easily reach to each section of regulations with customized view options. This is a convenient information and reference tool for all people working in pharmaceutical and biotech industry.
Keywords : Good Laboratory Practice (GLP), non-clinical study, FDA, Regulation, Regulatory
Tags: gmp booklet , fda glp booklets , epa-fda glp booklets