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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER C--DRUGS: GENERAL
 
PART 211CURRENT 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.

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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