GMP or Good Manufacturing Practice are the regulations promulgated by the US Food and Drug Administration under the authority of the Federal Food, Drug, and Cosmetic Act of the United States. These regulations require that manufacturers, processors, and packagers of drugs, medical devices, some food, and blood take definitive measures to ensure that their products are safe, pure, and effective.

The regulations laid down by GMP require strict adherence to quality in manufacturing, which enables companies to ensure the safety of their products and avoid errors. This offers consumers high protection as they purchase only safe products. GMP regulations are enforceable by law and failure in compliance can result in product recall, fines, and other penalties.

GMP regulations cover record keeping, personnel qualifications, sanitation, cleanliness, equipment verification, process validation, and complaint handling among other issues. GMP requirements are general which gives manufacturers the flexibility to interpret which controls are suitable for the business and how to implement them for optimal results.