What is Current Good Manufacturing Practice (CGMP)?
CGMP provides for the methods to be used in and the facilities or controls to be used for the manufacturing, processing, packing or holding a drug to assure the drug meets the safety, requirements of the Federal Food Drug and Cosmetic Act and that the drug has the identity, strength, and quality and purity characteristics it is represented to possess. The agency’s risk and science based approaches under the CGMP initiative are aimed at ensuring that regulatory review, compliance and inspection policies are based on state-of-the-art pharmaceutical science, and do not impede rapid adoption of new technological advances by the pharmaceutical industry.
