Pharmaceutical quality starts with the manufacturing process. Current Good Manufacturing Practice (CGMPs) regulations are enforced by the FDA. This regulation ensures that drug manufacturers use the proper design, monitoring, and control systems for medication production. These processes assure that strength, quality, purity, and identity are maintained across the market. CGMP also makes sure that the raw materials, quality assurance testing, and facility management are above minimum standards. Regardless of the drug being manufactured these main steps are followed: Design Conception, Manufacture, Extraction, Supply, Alteration, Packaging, and then Release. The U.S. Food and Drug Administration (FDA) is responsible for monitoring manufacturers of medications available in the consumer market. Its origins lie with Lewis Caleb Beck in 1848. The World Health Organization (WHO) is also involved in U.S. drug regulation as well as all other countries. These governing bodies ensure that the medications we consume are effective, safe, and of quality. The principal areas of drug regulation are listed below.
o Access the safety, effectiveness, quality and marketing authorizations of drugs
o Licensing and Inspection of manufacturers, wholesalers, and dispensaries
o Monitoring quality of available medications
o Controlling advertising of medications
o Monitoring safety of medications
o Providing independent drug information to professional and consumer populations