Compliance with Good Manufacturing Practice
Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act provides, in part, that a drug is adulterated if “the methods used in, or the facilities or controls used for its manufacture, processing, packing, or holding do not conform to current good manufacturing practice...” The Current Good Manufacturing Practice regulations, 21 CFR 210 and 211, or CGMP, convey requirements to ensure that all members of the drug industry, including those who make PET radiopharmaceuticals, are aware of the level of performance expected of them to be in compliance with the Act.
KeywordsDrug Product Good Manufacture Practice Current Good Manufacture Practice Aseptic Operation Quality Assurance Model
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