21 CFR Part 211 CGMP Guidelines For Finished Pharmaceuticals

21 CFR PART 211—CURRENT GOOD MANUFACTURING PRACTICE GUIDELINES FOR FINISHED PHARMACEUTICALS


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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.


21 CFR Part 211 CGMP Guidelines For Finished Pharmaceuticals

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