ABSTRACT
Legislation for Good Manufacturing Practices (GMP) was developed to ensure that producers of drugs, biologics and medical devices maintain a level of quality, safety, and consistency during manufacturing. The laws are upheld and enforced by the Food and Drug Administration (FDA). Enforcement is primarily by various types of facility inspections for drugs or devices marketed in the U.S. Failure of a producer to comply with any GMP regulation shall be subject to regulatory enforcement action. The cGMPs apply to any product intended for interstate commerce in the U.S.
