what is cgmp

CGMP stands for Current Good Manufacturing Practice, which is a set of regulations enforced by the FDA to ensure the quality of pharmaceutical products, medical devices, biotechnology products, food and beverage, and dietary supplements. The "c" in CGMP stands for "current," reminding manufacturers that they must employ technologies and systems which are up-to-date to comply with the regulation. CGMP provides for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. The regulations contain minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packaging of a product. If CGMP is followed, organizations can avoid many of the most common causes of quality failure which threaten patient safety, such as drug contamination, deviations, or mix-ups. CGMP applies to facilities and buildings, production, equipment, process controls, laboratory controls, packaging, and labeling, and returned or salvaged drug products.