21 CFR Part 211

21 CFR Part 211 is a U.S. regulation that sets quality standards for manufacturing, processing, and packaging of pharmaceuticals to ensure their safety, identity, strength, quality, and purity. It requires companies to have thorough documentation, proper procedures, trained personnel, and quality control measures. The goal is to prevent contamination, errors, and substandard products, ensuring medicines are safe and effective for consumers. Essentially, it’s a legal framework that guides pharmaceutical companies to produce high-quality medications consistently.