21CFR 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
