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Code of Federal Regulations (Last Updated: October 10, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter C - Drugs: General |
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Part 211 - Current Good Manufacturing Practice for Finished Pharmaceuticals |
| Subpart A - General Provisions |
| § 211.1 - Scope. |
| § 211.3 - Definitions. |
| Subpart B - Organization and Personnel |
| § 211.22 - Responsibilities of quality control unit. |
| § 211.25 - Personnel qualifications. |
| § 211.28 - Personnel responsibilities. |
| § 211.34 - Consultants. |
| Subpart C - Buildings and Facilities |
| § 211.42 - Design and construction features. |
| § 211.44 - Lighting. |
| § 211.46 - Ventilation, air filtration, air heating and cooling. |
| § 211.48 - Plumbing. |
| § 211.50 - Sewage and refuse. |
| § 211.52 - Washing and toilet facilities. |
| § 211.56 - Sanitation. |
| § 211.58 - Maintenance. |
| Subpart D - Equipment |
| § 211.63 - Equipment design, size, and location. |
| § 211.65 - Equipment construction. |
| § 211.67 - Equipment cleaning and maintenance. |
| § 211.68 - Automatic, mechanical, and electronic equipment. |
| § 211.72 - Filters. |
| Subpart E - Control of Components and Drug Product Containers and Closures |
| § 211.80 - General requirements. |
| § 211.82 - Receipt and storage of untested components, drug product containers, and closures. |
| § 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. |
| § 211.87 - Retesting of approved components, drug product containers, and closures. |
| § 211.89 - Rejected components, drug product containers, and closures. |
| § 211.94 - Drug product containers and closures. |
| Subpart F - Production and Process Controls |
| § 211.100 - Written procedures; deviations. |
| § 211.101 - Charge-in of components. |
| § 211.103 - Calculation of yield. |
| § 211.105 - Equipment identification. |
| § 211.110 - Sampling and testing of in-process materials and drug products. |
| § 211.111 - Time limitations on production. |
| § 211.113 - Control of microbiological contamination. |
| § 211.115 - Reprocessing. |
| Subpart G - Packaging and Labeling Control |
| § 211.122 - Materials examination and usage criteria. |
| § 211.125 - Labeling issuance. |
| § 211.130 - Packaging and labeling operations. |
| § 211.132 - Tamper-evident packaging requirements for over-the-counter (OTC) human drug products. |
| § 211.134 - Drug product inspection. |
| § 211.137 - Expiration dating. |
| Subpart H - Holding and Distribution |
| § 211.142 - Warehousing procedures. |
| § 211.150 - Distribution procedures. |
| Subpart I - Laboratory Controls |
| § 211.160 - General requirements. |
| § 211.165 - Testing and release for distribution. |
| § 211.166 - Stability testing. |
| § 211.167 - Special testing requirements. |
| § 211.170 - Reserve samples. |
| § 211.173 - Laboratory animals. |
| § 211.176 - Penicillin contamination. |
| Subpart J - Records and Reports |
| § 211.180 - General requirements. |
| § 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. |
| § 211.192 - Production record review. |
| § 211.194 - Laboratory records. |
| § 211.196 - Distribution records. |
| § 211.198 - Complaint files. |
| Subpart K - Returned and Salvaged Drug Products |
| § 211.204 - Returned drug products. |
| § 211.208 - Drug product salvaging. |