Current Good Manufacturing Practices (cGMPs) are formal regulations set forth by the Food and Drug Administration (FDA) in the United States regarding the design, monitoring, control, and maintenance of manufacturing processes and facilities. The FDA regulates compliance with cGMPs, and noncompliance with these regulations carries criminal penalties for pharmaceutical and biotechnology companies. The purpose of cGMPs is to ensure that products meet specific requirements, such as characteristics, strength, quality, and purity.
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