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