Current Good Manufacturing Practice (CGMP) Regulations
The Food and Drug Administration (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 can issue a warning letter or initiate other regulatory actions against a company that fails to comply with Current Good Manufacturing Practice regulations. Failure to comply can also lead to a decision by FDA not to approve an application to market a drug.
This web page provides links to resources to help drug manufacturers comply with the Current Good Manufacturing Practice regulations.
Good Manufacturing Practice regulations (GMPs) are used by pharmaceutical, medical device, and food manufacturers as they produce and test products that people use. Drug GMPs also apply to the veterinary drugs. In the United States, the U.S. Food and Drug Administration (FDA) has issued these regulations as the minimum requirements. This site helps you access the GMP regulations called current Good Manufacturing Practices and provides a special emphasis on the drug cGMPs. Most countries have their own GMPs for drug and medical device manufacturers.
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