What Is GMP

GMP is the acronym that refers to the Good Manufacturing Practice regulations promulgated by the US Food and Drug Administration under the authority of the Federal Food, Drug, and Cosmetic Act. It is a concept that ensures products are consistently produced and controlled according to quality standards. 

These regulations, which possess the force of law, need that manufacturers, packagers of drugs, and processors, medical devices, some food and blood take steps proactively to make sure that their products are safe, pure, and effective.

GMP regulations require a quality approach to manufacturing, allowing companies to minimize or eliminate possibilities of mix ups, contamination and errors. This protects the customer from buying a product which is not effective or even dangerous. Failure of companies to comply with GMP regulations can result in very serious repercussions including recall, fines, seizure, and jail time.

GMP regulations address issues including record keeping, equipment verification, process validation, personnel qualifications, complaint handling, sanitation, and cleanliness. Most GMP needs are very general and open-ended, enabling each manufacturer to decide individually how to best execute the mandatory controls. 

It is also sometimes referred to as "cGMP". The "c" represents the "current," reminding manufacturers that they should employ technologies and systems that are up-to-date in order to comply with the regulation.

GMP guidelines are not just any prescriptive instructions on how to manufacture products. They are a series of general principles that should be applied during manufacturing.