No, FDA is the only source of policy on pharmaceutical CGMPs and quality. CGMP requirements are found in statutes and regulations, and FDA’s current thinking on these requirements is explained in the Agency’s guidance documents.
The U.S. Pharmacopeial Convention is a private, nongovernmental organization that publishes the United States Pharmacopeia (USP) and the National Formulary (NF) as official compendia of the United States. Although much of the USP and NF is legally enforceable, the USP general chapters numbered above <999> (general information chapters) are informational and generally do not contain any mandatory requirements (see USP General Notices 2.10). General information chapters might include some recommendations that may help a firm meet CGMPs.
