Title 21 – Food and Drugs

Volume: 4

Date: 2014-04-01

Title: PART 211 – CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS

Context: Title 21 – Food and Drugs.

CHAPTER I – FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED). SUBCHAPTER C – DRUGS: GENERAL.

PART 211—CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS

Subpart A—General Provisions
Sec. 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

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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.

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