what is gmp in pharma

Good Manufacturing Practice (GMP) is a system for ensuring that pharmaceutical products are consistently produced and controlled according to quality standards. GMP covers all aspects of production from the starting materials, premises, and equipment to the training and personal hygiene of staff. The main risks that GMP aims to minimize are unexpected contamination of products, incorrect labels on containers, and other mistakes that could cause harm to patients. GMP regulations require a quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mix-ups, and errors. GMP regulations address issues including record keeping, personnel qualifications, sanitation, cleanliness, equipment verification, process validation, and complaint handling. The approval process for new and generic drug marketing applications includes a review of the manufacturers compliance with the CGMPs. Failure of firms to comply with GMP regulations can result in serious consequences including recall, seizure, fines, and jail time.