21 CFR PART 211—CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS ...

Title 21 of the Code of Federal Regulations (21 CFR) serves as the cornerstone of regulatory guidance in the United States for industries related to food and drugs. Among its comprehensive sections, 21 CFR Part 211 stands as a pivotal set of regulations governing Current Good Manufacturing Practice (cGMP) for Finished Pharmaceuticals. These regulations, issued and enforced by the U.S. Food and Drug Administration (FDA), provide a robust framework designed to ensure the quality, safety, and efficacy of pharmaceutical products throughout their lifecycle. The primary objective of 21 CFR Part 211 is to establish and maintain a uniform standard of manufacturing practices for finished pharmaceuticals. By doing so, the regulation seeks to safeguard public health by assuring that drug products are consistently produced with the appropriate identity, strength, quality, and purity. As an integral component of the broader cGMP framework, these regulations guide pharmaceutical manufacturers in creating and maintaining ...