Why GMP? An Explanation of Good Manufacturing Practice.
GMP refers to the Good Manufacturing Practice Regulations published by the FDA under the Federal Food, Drug, and Cosmetic Act. As a response to concerns about substandard drug manufacturing practices occurring at the time, Congress enacted the 1962 Drug Amendments. These amendments instructed the FDA to require all drugs to be made according to Good Manufacturing Practice (GMP) as defined under FDA 21 C FR Pa rt 2 10-211. The first set of Good Manufacturing Practices (GMP) or custom manufacturing regulations were published in 1963. These regulations are meant to guide companies in the production of safe and effective drugs. The regulations outlined in the GMPs are the minimum requirements necessary to ensure safe and effective products. In this blog, we'll discuss the definition of GMP, various regulatory components, and why it's important for companies in the life sciences space. Trained inspectors for the FDA examine facilities around the world, including those facil