Current Good Manufacturing Practices (cGMP) are the regulatory requirements described in section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)(21 U.S.C. 351 (a)(2)(B)), which state the manufacturing conditions that must exist for a drug product manufacturer to supply drug that is not considered “adulterated” (21 CFR parts 210 and 211)
FDA ensures the quality of drug products by carefully monitoring drug manufacturers’ compliance with its Current Good Manufacturing Practice (CGMP) regulations. The CGMP regulations for drugs contain minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product. The regulations make sure that a product is safe for use, and that it has the ingredients and strength it claims to have.
The approval process for new drug and generic drug marketing applications includes a review of the manufacturer’s compliance with the CGMP. FDA inspectors determine whether the firm has the necessary facilities, equipment, and skills to manufacture the new drug for which it has applied for approval. Decisions regarding compliance with CGMP regulations are based upon inspection of the facilities, sample analyses, and compliance history of the firm. This information is summarized in reports which represent several years of history of the firms.
FDA understands that the information that is available on the manufacture of investigational products, especially Phase I investigational products may be limited, however, consistent with the FD&C Act (§ 501(a) (2) (B)), CGMP must be in effect for the manufacture of each batch of investigational drug used during phase 1 clinical trials. FDA has established specific guidance on the CGMP controls that should be in place at Phase I that are based on identified hazards for the manufacturing setting that follow good scientific and QC principles. As the product progresses from Phase 1 through later phases of clinical development and more information is gained on the manufacturing process and controls, the FDA expected compliance to full CGMP requirements progresses and complete compliance to CGMPs should be in place by the time the product is marketed.
