TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER C - DRUGS: GENERAL
Part 211 - Current Good Manufacturing Practice For Finished Pharmaceuticals
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Subpart B—Organization and Personnel
211.22 Responsibilities of quality control unit.
211.25 Personnel qualifications.
211.28 Personnel responsibilities.
Subpart C—Buildings and Facilities
211.42 Design and construction features.
211.46 Ventilation, air filtration, air heating and cooling.
211.52 Washing and toilet facilities.
211.63 Equipment design, size, and location.
211.65 Equipment construction.
211.67 Equipment cleaning and maintenance.
211.68 Automatic, mechanical, and electronic equipment.
Subpart E—Control of Components and Drug Product Containers and Closures
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.
211.105 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.
Subpart G—Packaging and Labeling Control
211.122 Materials examination and usage criteria.
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.
Subpart H—Holding and Distribution
211.142 Warehousing procedures.
211.150 Distribution procedures.
211.165 Testing and release for distribution.
211.167 Special testing requirements.
211.176 Penicillin contamination.
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.
Subpart K—Returned and Salvaged Drug Products
211.204 Returned drug products.
211.208 Drug product salvaging.
21 CFR Part 211 CGMP Guidelines For Finished Pharmaceuticals