ABSTRACT
The U.S. Food and Drug Administration regulates the manufacture and distribution of pharmaceuticals, foods, cosmetics, medical devices, and biological products under the authority of the Food, Drug, and Cosmetic Act (21 USC) and the Public Health Service Act (42 USC). General requirements for validation can be found in Title 21 of the Code of Federal Regulations (CFR) under the headings “Good Manufacturing Practices (GMPs),” “Good Laboratory Practices (GLPs),” and “Good Clinical Practices (GCPs).”
