![]() ![]() ![]() Code of Federal Regulations (CFR)įDA's portion of the CFR is in Title 21, which interprets the Federal Food, Drug and Cosmetic Actand related statutes, including the Public Health Service Act. FDA assessors and investigators determine whether the firm has the necessary facilities, equipment, and ability to manufacture the drug it intends to market. The approval process for new and generic drug marketing applications includes a review of the manufacturer's compliance with the CGMP. The regulations make sure that a product is safe for use, and that it has the ingredients and strength it claims to have. The CGMP regulations for drugs contain minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product. (May 2023): Immediately in Effect Guidance for Industry: Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution, and other High-Risk Drug Components for Diethylene Glycol and Ethylene GlycolįDA ensures the quality of drug products by carefully monitoring drug manufacturers' compliance with its Current Good Manufacturing Practice (CGMP) regulations.
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |