21 CFR Part 211 (Current Good Manufacturing Practice for Finished Pharmaceuticals)

21 CFR Part 211 is a set of regulations by the U.S. Food and Drug Administration (FDA) that outlines standards for manufacturing, processing, and packaging finished pharmaceutical products to ensure their safety, quality, and effectiveness. It requires pharmaceutical companies to maintain proper records, follow strict procedures, validate processes, and ensure cleanliness and control in their facilities. Essentially, it establishes the legal framework for producing safe medicines, emphasizing consistency, quality control, and accountability throughout the manufacturing process.