Must each batch of a United States Pharmacopeia (USP)-grade API be tested using the analytical procedures specified in the USP monograph?
Must each batch of a United States Pharmacopeia (USP)-grade API be tested using the analytical procedures specified in the USP monograph?
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No; however, in the event of a dispute, the compendial method is considered conclusive (see USP reference, below). Section 201(g) of the FD&C Act includes “articles intended for use as a component” of a finished drug product, including APIs (or drug substances), under its definition of a drug, and section 501(b) requires a drug recognized in USP to meet the standards of strength, quality, and purity in the official monograph or to be clearly labeled to designate how it differs from USP standards. Although each batch of a compendial article must conform to the monograph specifications/acceptance criteria, the analytical procedures used to show conformance may differ from official USP methods if the alternative methods are fully validated, suitable for use, and give equivalent or better results than the official USP method. All APIs must also be manufactured in compliance with CGMP as stated in section 501(a)(2)(B) of the FD&C Act.
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Date: 6/9/2015