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Current Good Manufacturing Practice

"Current" Good Manufacturing Practice as put forth in various guidelines through the combined efforts of the FDA, U.S. Department of Health and Human Services, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER) and Center for Veterinary Medicine (CVM). These guidelines, without providing specific methodology, identify the expectations of the FDA in regard to the design, construction and operation of facilities intended for the manufacturing, processing, packing or holding of API’s.