What US 21 CFR Part 211: Current Good Manufacturing Practice for Finished Pharmaceuticals requires
US 21 CFR Part 211 prescribes the cGMP requirements for finished pharmaceuticals manufactured, processed, packed, or held in the US. Subparts cover organization and personnel, buildings and facilities, equipment, control of components, production and process controls, packaging and labeling, holding and distribution, laboratory controls, records and reports, returned and salvaged drug products. FDA inspectors evaluate establishments against Part 211 during pre-approval inspections and routine surveillance. Non-compliance findings drive Form FDA 483 observations, Warning Letters, consent decrees, and import alerts. Part 211 is the operational backbone of US drug quality assurance.
Pillar: Pharmaceuticals & Life Sciences · Authority: US FDA · Version: 1.0.0 · Last updated:
Primary source: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211
SHA-256 integrity: 326bf80c890d96f424d015fd638767b3efd1cc04330dfeccf705ff16c8d2068b
Primary Citations — 5 traced to source
- US 21 CFR Current Good Manufacturing Practice for Finished Pharmaceuticals
- US 21 CFR § 211.22 Responsibilities of quality control unit
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