USFDA GMP Guideline FOR Pharmaceutical Products - 21 CFR PART 211
21 CFR Part 211: A Guide to Good Manufacturing Practice for Pharmaceutical Products (Part 211 in Title 21 of Code Of Federal Regulations) Introduction: The pharmaceutical industry is heavily regulated to ensure the quality and safety of drugs. In the United States, the Food and Drug Administration (FDA) sets guidelines for good manufacturing practice (GMP) through the Code of Federal Regulations (CFR). 21 CFR Part 211 is a critical regulation that outlines the minimum requirements for the manufacture, processing, packing, or holding of pharmaceutical products. In this blog, we'll delve into the key aspects of 21 CFR Part 211 and its significance in ensuring the quality of pharmaceutical products. Scope and Applicability: 21 CFR Part 211 applies to all pharmaceutical products, including prescription and over-the-counter (OTC) drugs, biologics, and combination products. The regulation covers various aspects of pharmaceutical manufacturing, including: - Personnel qualifications and tr...
