21 CFR Part 211 - Current Good Manufacturing Practice for Finished Pharmaceuticals

The FDA's core CGMP regulation for finished pharmaceuticals, covering organisation and personnel, buildings and facilities, equipment, control of components, production and process controls, packaging and labelling, holding and distribution, laboratory controls, records and reports, and returned and salvaged drug products. Amended by 89 FR 51769 (18 June 2024, effective 18 December 2025) to exclude medical gases.

Organizations:

FDA