PART 211 - CURRENT GOOD MANUFACTURING PRACTICE FORFINISHED 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.

Authority: 21 U.S.C. 321, 351, 352, 355, 360b, 371, 374; 42 U.S.C. 216, 262, 263a, 264.

Source: 43 FR 45077, Sept. 29, 1978, unless otherwise noted.