GMP 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 (See Chapter IV for food, and Chapter V, Subchapters A, B, C, D, and E for drugs
and devices.) These regulations, which have the force of law, require that manufacturers,
processors, and packagers of drugs, medical devices, some food, and blood take proactive
steps to ensure that their products are safe, pure, and effective. GMP regulations
require a quality approach to manufacturing, enabling companies to minimize or eliminate
instances of contamination, mixups, and errors. This in turn, protects the consumer
from purchasing a product which is not effective or even dangerous. Failure of firms
to comply with GMP regulations can result in very serious consequences including recall,
seizure, fines, and jail time.
GMP regulations address issues including recordkeeping, personnel qualifications,
sanitation, cleanliness, equipment verification, process validation, and complaint
handling. Most GMP requirements are very general and open-ended, allowing each manufacturer
to decide individually how to best implement the necessary controls. This provides
much flexibility, but also requires that the manufacturer interpret the requirements
in a manner which makes sense for each individual business.
GMP is also sometimes referred to as "cGMP". The "c" stands for "current," reminding
manufacturers that they must employ technologies and systems which are up-to-date
in order to comply with the regulation. Systems and equipment used to prevent contamination,
mixups, and errors, which may have been "top-of-the-line" 20 years ago, may be less
than adequate by today's standards.