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What are FDA's cGMP requirements for drugs and biologics?
FDA's cGMP requirements for drugs are the requirements for the methods to be used in, and the facilities or controls to be used for, the manufacture, processing, packing, or holding of a drug (including a biologic) to assure that such drug meets the requirements of the Act as to safety, and has the identity and strength and meets the quality and purity characteristics that it purports or is represented to possess (21 CFR Parts 210 and 211). Biological products, depending on their intended use, must meet the cGMP requirements for either drugs or devices. Supplementary requirements for biological products are in 21 CFR Parts 600-680.
U.S. Food and Drug Administration (FDA)
http://www.fda.gov
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