GMP Good Manufacturing Practice

(GMP) is a system that ensures that products are consistently produced and controlled in accordance with quality standards. It is designed to minimize the risks that arise in any pharmaceutical production that cannot be eliminated by testing the final product.

GMP covers all aspects of production, from starting materials, premises and equipment to staff training and personal hygiene. Detailed written procedures are crucial for any process that may affect the quality of the finished product. There must be systems that provide documented evidence that the correct procedures are consistently followed at every step of the manufacturing process – every time a product is made.

GMP regulations require a quality approach to production, allowing companies to reduce or eliminate cases of contamination, mixing, and error. This protects the consumer from buying a product that is not effective or even dangerous. Failure to comply with GMP regulations can result in very serious consequences, including recall, forfeiture, fines, and imprisonment.

GMP regulations address issues that include record keeping, staff qualifications, sanitation, equipment inspection, process inspection, and grievance redress. Most GMP requirements are very general and open, allowing each manufacturer to decide individually how best to implement the necessary controls. This provides great flexibility, but also requires the manufacturer to interpret the requirements in a way that makes sense for each individual business.