21 CFR
Part 211 Current Good Manufacturing Practice for Finished Pharmaceuticals
Subpart A - General Provisions
Subpart B - Organization and Personnel
- § 211.22 Responsibilities of quality control unit 3,474 × 483
- § 211.25 Personnel qualifications 1,569 × 483
- § 211.28 Personnel responsibilities 311 × 483
- § 211.34 Consultants 14 × 483
Subpart C - Buildings and Facilities
- § 211.42 Design and construction features 1,650 × 483
- § 211.44 Lighting 19 × 483
- § 211.46 Ventilation, air filtration, air heating and cooling 224 × 483
- § 211.48 Plumbing 58 × 483
- § 211.50 Sewage and refuse 5 × 483
- § 211.52 Washing and toilet facilities 63 × 483
- § 211.56 Sanitation 443 × 483
- § 211.58 Maintenance 319 × 483
Subpart D - Equipment
- § 211.63 Equipment design, size, and location 697 × 483
- § 211.65 Equipment construction 55 × 483
- § 211.67 Equipment cleaning and maintenance 2,452 × 483
- § 211.68 Automatic, mechanical, and electronic equipment 1,645 × 483
- § 211.72 Filters
Subpart E - Control of Components and Drug Product Containers and Closures
- § 211.80 General requirements 669 × 483
- § 211.82 Receipt and storage of untested components, drug product containers, and closures 65 × 483
- § 211.84 Testing and approval or rejection of components, drug product containers, and closures 1,796 × 483
- § 211.86 Use of approved components, drug product containers, and closures 8 × 483
- § 211.87 Retesting of approved components, drug product containers, and closures 60 × 483
- § 211.89 Rejected components, drug product containers, and closures 43 × 483
- § 211.94 Drug product containers and closures 100 × 483
Subpart F - Production and Process Controls
- § 211.100 Written procedures; deviations 2,655 × 483
- § 211.101 Charge-in of components 162 × 483
- § 211.103 Calculation of yield 169 × 483
- § 211.105 Equipment identification 133 × 483
- § 211.110 Sampling and testing of in-process materials and drug products 1,105 × 483
- § 211.111 Time limitations on production 211 × 483
- § 211.113 Control of microbiological contamination 1,388 × 483
- § 211.115 Reprocessing 100 × 483
Subpart G - Packaging and Labeling Control
- § 211.122 Materials examination and usage criteria 313 × 483
- § 211.125 Labeling issuance 469 × 483
- § 211.130 Packaging and labeling operations 354 × 483
- § 211.132 Tamper-evident packaging requirements for over-the-counter (OTC) human drug products 1 × 483
- § 211.134 Drug product inspection 74 × 483
- § 211.137 Expiration dating 342 × 483
Subpart H - Holding and Distribution
- § 211.142 Warehousing procedures 555 × 483
- § 211.150 Distribution procedures 270 × 483
Subpart I - Laboratory Controls
- § 211.160 General requirements 3,033 × 483
- § 211.165 Testing and release for distribution 1,898 × 483
- § 211.166 Stability testing 1,727 × 483
- § 211.167 Special testing requirements 168 × 483
- § 211.170 Reserve samples 496 × 483
- § 211.173 Laboratory animals 1 × 483
- § 211.176 Penicillin contamination 16 × 483
Subpart J - Records and Reports
- § 211.180 General requirements 1,050 × 483
- § 211.182 Equipment cleaning and use log 324 × 483
- § 211.184 Component, drug product container, closure, and labeling records 105 × 483
- § 211.186 Master production and control records 596 × 483
- § 211.188 Batch production and control records 1,448 × 483
- § 211.192 Production record review 2,789 × 483
- § 211.194 Laboratory records 1,189 × 483
- § 211.196 Distribution records 71 × 483
- § 211.198 Complaint files 1,216 × 483
Subpart K - Returned and Salvaged Drug Products
- § 211.204 Returned drug products 110 × 483
- § 211.208 Drug product salvaging 10 × 483