Part 211 — Current Good Manufacturing Practice for Finished Pharmaceuticals
Current through Sep 8, 2026
Authority: 21 U.S.C. 321, 351, 352, 355, 360b, 360ddd, 360ddd-1, 371, 374; 42 U.S.C. 216, 262, 263a, 264.
Source: 43 FR 45077, Sept. 29, 1978, unless otherwise noted.
Sections
- § 211.1 Scope.
- § 211.3 Definitions.
- § 211.22 Responsibilities of quality control unit.
- § 211.25 Personnel qualifications.
- § 211.28 Personnel responsibilities.
- § 211.34 Consultants.
- § 211.42 Design and construction features.
- § 211.44 Lighting.
- § 211.46 Ventilation, air filtration, air heating and cooling.
- § 211.48 Plumbing.
- § 211.50 Sewage and refuse.
- § 211.52 Washing and toilet facilities.
- § 211.56 Sanitation.
- § 211.58 Maintenance.
- § 211.63 Equipment design, size, and location.
- § 211.65 Equipment construction.
- § 211.67 Equipment cleaning and maintenance.
- § 211.68 Automatic, mechanical, and electronic equipment.
- § 211.72 Filters.
- § 211.80 General requirements.
- § 211.82 Receipt and storage of untested components, drug product containers, and closures.
- § 211.84 Testing and approval or rejection of components, drug product containers, and closures.
- § 211.86 Use of approved components, drug product containers, and closures.
- § 211.87 Retesting of approved components, drug product containers, and closures.
- § 211.89 Rejected components, drug product containers, and closures.
- § 211.94 Drug product containers and closures.
- § 211.100 Written procedures; deviations.
- § 211.101 Charge-in of components.
- § 211.103 Calculation of yield.
- § 211.105 Equipment identification.
- § 211.110 Sampling and testing of in-process materials and drug products.
- § 211.111 Time limitations on production.
- § 211.113 Control of microbiological contamination.
- § 211.115 Reprocessing.
- § 211.122 Materials examination and usage criteria.
- § 211.125 Labeling issuance.
- § 211.130 Packaging and labeling operations.
- § 211.132 Tamper-evident packaging requirements for over-the-counter (OTC) human drug products.
- § 211.134 Drug product inspection.
- § 211.137 Expiration dating.
- § 211.142 Warehousing procedures.
- § 211.150 Distribution procedures.
- § 211.160 General requirements.
- § 211.165 Testing and release for distribution.
- § 211.166 Stability testing.
- § 211.167 Special testing requirements.
- § 211.170 Reserve samples.
- § 211.173 Laboratory animals.
- § 211.176 Penicillin contamination.
- § 211.180 General requirements.
- § 211.182 Equipment cleaning and use log.
- § 211.184 Component, drug product container, closure, and labeling records.
- § 211.186 Master production and control records.
- § 211.188 Batch production and control records.
- § 211.192 Production record review.
- § 211.194 Laboratory records.
- § 211.196 Distribution records.
- § 211.198 Complaint files.
- § 211.204 Returned drug products.
- § 211.208 Drug product salvaging.