FDA 21 CFR Part 211

FDA 21 CFR Part 211 is a set of detailed regulations that pharmaceutical companies must follow to ensure the quality, safety, and effectiveness of their medicines. It covers all aspects of drug manufacturing, including how ingredients are sourced, how the drugs are produced, tested, stored, and documented. These rules require rigorous quality control, proper record-keeping, and validation of processes to prevent contamination or errors. Essentially, it serves as a comprehensive guide to maintain high standards and protect public health throughout the pharmaceutical manufacturing lifecycle.