ASQ Princeton Section 307 is dedicated to serving and advancing the cause of quality in every segment of our community by supporting our members with valuable opportunities for learning, networking, and knowledge exchange.
refresh your skills: GMP (Good Manufacturing Practices) are requirements minimizing risks to ensure that products -- pharmaceuticals, foods, and cosmetics -- are consistently produced and controlled according to quality standards. In 1938, following the death of over 100 people from a toxic antibiotic “elixir,” the Food Drug Agency (FDA) introduced the Food, Drug and Cosmetic Act, which established a factory inspection system. A second catastrophe in 1941 led the FDA to strengthen its manufacturing controls, creating the precursors to today’s GMPs, codified in 1963. In the USA, the FDA is responsible for these, often using "cGMP" (current GMP) to mean updated, modern standards. Details of FDA requirements can be found in the searchable Code of Federal Regulations, Title 21.