Title 21

PART 211

Part 211 - Current Good Manufacturing Practice For Finished Pharmaceuticals

PART 211 - CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Authority:21 U.S.C. 321, 351, 352, 355, 360b, 371, 374; 42 U.S.C. 216, 262, 263a, 264. Source:43 FR 45077, Sept. 29, 1978, unless otherwise noted.

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