Home/CFR/Title 21/Part 211
FEDERAL · 21 CFR

Part 211 — Current Good Manufacturing Practice for Finished Pharmaceuticals

60 sections · Title 21: Food and Drugs

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