The Code of Federal Regulations (CFR) is a codification of the general and permanent rules published in the Federal Register by the Executive departments and agencies of the Federal Government. FDA 21 CFR Part 211 covers the areas for finished drug products, such as labeling, production processes, equipment management and personnel.
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.
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