21 CFR Part 320

21 CFR Part 320 outlines regulations for establishing and maintaining methods to ensure drug product quality, safety, and effectiveness. It specifies procedures for testing, data collection, and documentation to verify that pharmaceuticals meet required standards before they reach consumers. The regulation emphasizes the importance of validated processes, accurate records, and consistent quality control measures throughout drug manufacturing. Essentially, it guides pharmaceutical companies on how to systematically ensure their products are safe, effective, and compliant with legal requirements, protecting public health by maintaining rigorous quality assurance practices.