Pharmaceutical cleanrooms are regulated by FDA in the United States and EMA in Europe. Pharmaceutical cleanrooms must meet CGMP. Per the FDA GMP refers to the Current Good Manufacturing Practice regulations enforced by the FDA. Adherence to the CGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations. To simplify this, GMP helps to ensure the consistent quality and safety of products by focusing attention on five key elements, which are often referred to as the 5 P's of GMP—people, premises, processes, products, and procedures.
American Cleanroom Systems modular cleanroom systems have been used by numerous pharmaceutical manufacturers for their CGMP FDA validation cleanrooms. Pharmaceutical filling rooms are typically class 100/ISO5. Other rooms can be lower classification depending on specific use.