- Current Good Manufacturing Practice provides for systems that assure proper design, monitoring, and control of manufacturing processes and facilities.
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Current Good Manufacturing Practice (CGMP)
- The Current Good Manufacturing Practice regulations is enforced by the Food and Drug Administration (FDA).
- Food and Drug Administration ensures the quality of drug products by carefully monitoring drug manufacturers’ compliance with its Current Good Manufacturing Practice (CGMP) regulations.
Food and Drug Administration (FDA).
- The Food and Drug Administration (FDA or USFDA) is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments.
- FDA inspects pharmaceutical manufacturing facilities worldwide, including facilities that manufacture active ingredients and the finished product.
Why was Current Good Manufacturing Practice regulations in news?
- The U.S. Food and Drug Administration (FDA) found adulteration and “significant violations” of current good manufacturing practice (CGMP) regulations at Strides Pharma Sciences Ltd’s plant in Puducherry in south India.