Current Good Manufacturing Practices (CGMP)
Current Good Manufacturing Practices are a system for ensuring that regulated healthcare products, such as drugs and medical devices, are consistently produced and controlled according to quality standards. Manufacturers of these products must follow regulations to ensure that products have the safety, identify, potency, purity, and quality that they claim to have.
CGMP cover all aspects of production from the starting materials, premises, and equipment to the training and personal hygiene of staff. Detailed, written procedures are essential for each process that could affect the quality of the finished product. There must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process – every time a product is made.