21 CFR Part 211: CGMP for Finished Pharmaceuticals
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.
Subpart A—General Provisions
Subpart B—Organization and Personnel
- § 211.22 Responsibilities of quality control unit.3 warning lettersBatchGlow
- § 211.25 Personnel qualifications.BatchGlow
- § 211.28 Personnel responsibilities.
- § 211.34 Consultants.
Subpart C—Buildings and Facilities
- § 211.42 Design and construction features.BatchGlow
- § 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.
Subpart D—Equipment
- § 211.63 Equipment design, size, and location.BatchGlow
- § 211.65 Equipment construction.
- § 211.67 Equipment cleaning and maintenance.BatchGlow
- § 211.68 Automatic, mechanical, and electronic equipment.1 warning letterBatchGlow
- § 211.72 Filters.
Subpart E—Control of Components and Drug Product Containers and Closures
- § 211.80 General requirements.BatchGlow
- § 211.82 Receipt and storage of untested components, drug product containers, and closures.BatchGlow
- § 211.84 Testing and approval or rejection of components, drug product containers, and closures.6 warning lettersBatchGlow
- § 211.86 Use of approved components, drug product containers, and closures.BatchGlow
- § 211.87 Retesting of approved components, drug product containers, and closures.BatchGlow
- § 211.89 Rejected components, drug product containers, and closures.BatchGlow
- § 211.94 Drug product containers and closures.
Subpart F—Production and Process Controls
- § 211.100 Written procedures; deviations.4 warning lettersBatchGlow
- § 211.101 Charge-in of components.BatchGlow
- § 211.103 Calculation of yield.BatchGlow
- § 211.105 Equipment identification.BatchGlow
- § 211.110 Sampling and testing of in-process materials and drug products.BatchGlow
- § 211.111 Time limitations on production.BatchGlow
- § 211.113 Control of microbiological contamination.
- § 211.115 Reprocessing.BatchGlow
Subpart G—Packaging and Labeling Control
- § 211.122 Materials examination and usage criteria.BatchGlow
- § 211.125 Labeling issuance.BatchGlow
- § 211.130 Packaging and labeling operations.BatchGlow
- § 211.132 Tamper-evident packaging requirements for over-the-counter (OTC) human drug products.
- § 211.134 Drug product inspection.
- § 211.137 Expiration dating.1 warning letterBatchGlow
Subpart H—Holding and Distribution
Subpart I—Laboratory Controls
- § 211.160 General requirements.1 warning letterBatchGlow
- § 211.165 Testing and release for distribution.5 warning lettersBatchGlow
- § 211.166 Stability testing.1 warning letter
- § 211.167 Special testing requirements.
- § 211.170 Reserve samples.BatchGlow
- § 211.173 Laboratory animals.
- § 211.176 Penicillin contamination.
Subpart J—Records and Reports
- § 211.180 General requirements.BatchGlow
- § 211.182 Equipment cleaning and use log.BatchGlow
- § 211.184 Component, drug product container, closure, and labeling records.BatchGlow
- § 211.186 Master production and control records.BatchGlow
- § 211.188 Batch production and control records.2 warning lettersBatchGlow
- § 211.192 Production record review.3 warning lettersBatchGlow
- § 211.194 Laboratory records.BatchGlow
- § 211.196 Distribution records.
- § 211.198 Complaint files.BatchGlow