Good Manufacturing Practices (GMP)
In order to ensure the safety and efficacy of pharmaceutical products, the FDA mandates that manufacturers follow a set of methodologies and procedures known as Good Manufacturing Practices, or GMP. These guidelines are the FDA’s way of regulating production processes that are constantly changing as new technology enters the scene. Specific regulations governing pharmaceutical production are often not feasible when dealing with novel technologies. GMP guidelines establish best practices as they evolve and also provide for extensive record keeping that helps reviewers determine the best way to make a drug. Manufacturers turn to GMP guidelines for direction on how best to perform laboratory processes such as calibrating instruments, preventing contamination, verifying drug stability, and labeling pharmaceutical products.
The FDA has defined current Good Manufacturing Practices (GMP) in 21 CFR 210 and 211. These require drugs to meet quality, potency, and purity standards. In addition to delineating the required characteristics of drugs, GMPs also mandate specialized training and lab environmental controls such as instructions for ensuring freedom from vermin, instructions for how to build and maintain clean rooms, directives on how to house and handle lab animals, and strict policies for compliance. A full list of the FDA GMP guidelines is available here. The ICH also publishes GMP regulations.
