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