| Betterchem |
|
Drug Master File and cGMP Assistance The 21 CFR 211 Subparts below are provided as general information. Within each Subpart, our editors have included the corresponding guidance sections from FDA's Draft Guidance on Manufacturing, Processing, or Holding Active Pharmaceutical Ingredients. In Subparts 211.80 - 211.94 the CFR addresses "Control of Components and Drug Product Containers and Closures". These are the "raw materials" of a finished product. The corresponding raw material subject matter for API's includes starting materials, intermediates, solvents, mother liquors, second crops, process water, etc. CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES 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. | ||
| 211.63 | Equipment design, size, and location. | ||
| Subpart D Equipment | |||
| 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. | ||
| Related Validation… | Process Validation Strategy | ||
| Validation Protocol | |||
| Prospective Validation | |||
| Concurrent Validation | |||
| Retrospective Validation | |||
| Change-Control System | |||
| Change-Control Classification | |||
| Reprocessing | Reprocessing by Repeating a Chemical Reaction | ||
| Reprocessing by Physical Manipulations | |||
| Reworking of APIs and Intermediates | |||
|
© 2007 Betterchem Corp.