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