| 21:4.0.1.1.11.1 | SUBPART A
| Subpart A - General Provisions | |
| 21:4.0.1.1.11.1.1.1 | SECTION 211.1
| 211.1 Scope. | |
| 21:4.0.1.1.11.1.1.2 | SECTION 211.3
| 211.3 Definitions. | |
| 21:4.0.1.1.11.2 | SUBPART B
| Subpart B - Organization and Personnel | |
| 21:4.0.1.1.11.2.1.1 | SECTION 211.22
| 211.22 Responsibilities of quality control unit. | |
| 21:4.0.1.1.11.2.1.2 | SECTION 211.25
| 211.25 Personnel qualifications. | |
| 21:4.0.1.1.11.2.1.3 | SECTION 211.28
| 211.28 Personnel responsibilities. | |
| 21:4.0.1.1.11.2.1.4 | SECTION 211.34
| 211.34 Consultants. | |
| 21:4.0.1.1.11.3 | SUBPART C
| Subpart C - Buildings and Facilities | |
| 21:4.0.1.1.11.3.1.1 | SECTION 211.42
| 211.42 Design and construction features. | |
| 21:4.0.1.1.11.3.1.2 | SECTION 211.44
| 211.44 Lighting. | |
| 21:4.0.1.1.11.3.1.3 | SECTION 211.46
| 211.46 Ventilation, air filtration, air heating and cooling. | |
| 21:4.0.1.1.11.3.1.4 | SECTION 211.48
| 211.48 Plumbing. | |
| 21:4.0.1.1.11.3.1.5 | SECTION 211.50
| 211.50 Sewage and refuse. | |
| 21:4.0.1.1.11.3.1.6 | SECTION 211.52
| 211.52 Washing and toilet facilities. | |
| 21:4.0.1.1.11.3.1.7 | SECTION 211.56
| 211.56 Sanitation. | |
| 21:4.0.1.1.11.3.1.8 | SECTION 211.58
| 211.58 Maintenance. | |
| 21:4.0.1.1.11.4 | SUBPART D
| Subpart D - Equipment | |
| 21:4.0.1.1.11.4.1.1 | SECTION 211.63
| 211.63 Equipment design, size, and location. | |
| 21:4.0.1.1.11.4.1.2 | SECTION 211.65
| 211.65 Equipment construction. | |
| 21:4.0.1.1.11.4.1.3 | SECTION 211.67
| 211.67 Equipment cleaning and maintenance. | |
| 21:4.0.1.1.11.4.1.4 | SECTION 211.68
| 211.68 Automatic, mechanical, and electronic equipment. | |
| 21:4.0.1.1.11.4.1.5 | SECTION 211.72
| 211.72 Filters. | |
| 21:4.0.1.1.11.5 | SUBPART E
| Subpart E - Control of Components and Drug Product Containers and Closures | |
| 21:4.0.1.1.11.5.1.1 | SECTION 211.80
| 211.80 General requirements. | |
| 21:4.0.1.1.11.5.1.2 | SECTION 211.82
| 211.82 Receipt and storage of untested components, drug product containers, and closures. | |
| 21:4.0.1.1.11.5.1.3 | SECTION 211.84
| 211.84 Testing and approval or rejection of components, drug product containers, and closures. | |
| 21:4.0.1.1.11.5.1.4 | SECTION 211.86
| 211.86 Use of approved components, drug product containers, and closures. | |
| 21:4.0.1.1.11.5.1.5 | SECTION 211.87
| 211.87 Retesting of approved components, drug product containers, and closures. | |
| 21:4.0.1.1.11.5.1.6 | SECTION 211.89
| 211.89 Rejected components, drug product containers, and closures. | |
| 21:4.0.1.1.11.5.1.7 | SECTION 211.94
| 211.94 Drug product containers and closures. | |
| 21:4.0.1.1.11.6 | SUBPART F
| Subpart F - Production and Process Controls | |
| 21:4.0.1.1.11.6.1.1 | SECTION 211.100
| 211.100 Written procedures; deviations. | |
| 21:4.0.1.1.11.6.1.2 | SECTION 211.101
| 211.101 Charge-in of components. | |
| 21:4.0.1.1.11.6.1.3 | SECTION 211.103
| 211.103 Calculation of yield. | |
| 21:4.0.1.1.11.6.1.4 | SECTION 211.105
| 211.105 Equipment identification. | |
| 21:4.0.1.1.11.6.1.5 | SECTION 211.110
| 211.110 Sampling and testing of in-process materials and drug products. | |
| 21:4.0.1.1.11.6.1.6 | SECTION 211.111
| 211.111 Time limitations on production. | |
| 21:4.0.1.1.11.6.1.7 | SECTION 211.113
| 211.113 Control of microbiological contamination. | |
| 21:4.0.1.1.11.6.1.8 | SECTION 211.115
| 211.115 Reprocessing. | |
| 21:4.0.1.1.11.7 | SUBPART G
| Subpart G - Packaging and Labeling Control | |
| 21:4.0.1.1.11.7.1.1 | SECTION 211.122
| 211.122 Materials examination and usage criteria. | |
| 21:4.0.1.1.11.7.1.2 | SECTION 211.125
| 211.125 Labeling issuance. | |
| 21:4.0.1.1.11.7.1.3 | SECTION 211.130
| 211.130 Packaging and labeling operations. | |
| 21:4.0.1.1.11.7.1.4 | SECTION 211.132
| 211.132 Tamper-evident packaging requirements for over-the-counter (OTC) human drug products. | |
| 21:4.0.1.1.11.7.1.5 | SECTION 211.134
| 211.134 Drug product inspection. | |
| 21:4.0.1.1.11.7.1.6 | SECTION 211.137
| 211.137 Expiration dating. | |
| 21:4.0.1.1.11.8 | SUBPART H
| Subpart H - Holding and Distribution | |
| 21:4.0.1.1.11.8.1.1 | SECTION 211.142
| 211.142 Warehousing procedures. | |
| 21:4.0.1.1.11.8.1.2 | SECTION 211.150
| 211.150 Distribution procedures. | |
| 21:4.0.1.1.11.9 | SUBPART I
| Subpart I - Laboratory Controls | |
| 21:4.0.1.1.11.9.1.1 | SECTION 211.160
| 211.160 General requirements. | |
| 21:4.0.1.1.11.9.1.2 | SECTION 211.165
| 211.165 Testing and release for distribution. | |
| 21:4.0.1.1.11.9.1.3 | SECTION 211.166
| 211.166 Stability testing. | |
| 21:4.0.1.1.11.9.1.4 | SECTION 211.167
| 211.167 Special testing requirements. | |
| 21:4.0.1.1.11.9.1.5 | SECTION 211.170
| 211.170 Reserve samples. | |
| 21:4.0.1.1.11.9.1.6 | SECTION 211.173
| 211.173 Laboratory animals. | |
| 21:4.0.1.1.11.9.1.7 | SECTION 211.176
| 211.176 Penicillin contamination. | |
| 21:4.0.1.1.11.10 | SUBPART J
| Subpart J - Records and Reports | |
| 21:4.0.1.1.11.10.1.1 | SECTION 211.180
| 211.180 General requirements. | |
| 21:4.0.1.1.11.10.1.2 | SECTION 211.182
| 211.182 Equipment cleaning and use log. | |
| 21:4.0.1.1.11.10.1.3 | SECTION 211.184
| 211.184 Component, drug product container, closure, and labeling records. | |
| 21:4.0.1.1.11.10.1.4 | SECTION 211.186
| 211.186 Master production and control records. | |
| 21:4.0.1.1.11.10.1.5 | SECTION 211.188
| 211.188 Batch production and control records. | |
| 21:4.0.1.1.11.10.1.6 | SECTION 211.192
| 211.192 Production record review. | |
| 21:4.0.1.1.11.10.1.7 | SECTION 211.194
| 211.194 Laboratory records. | |
| 21:4.0.1.1.11.10.1.8 | SECTION 211.196
| 211.196 Distribution records. | |
| 21:4.0.1.1.11.10.1.9 | SECTION 211.198
| 211.198 Complaint files. | |
| 21:4.0.1.1.11.11 | SUBPART K
| Subpart K - Returned and Salvaged Drug Products | |
| 21:4.0.1.1.11.11.1.1 | SECTION 211.204
| 211.204 Returned drug products. | |
| 21:4.0.1.1.11.11.1.2 | SECTION 211.208
| 211.208 Drug product salvaging. | |