Title 21--Food and Drugs

CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES

PART 211--CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS

TEXT PDF211.1 Scope.
TEXT PDF211.3 Definitions.
TEXT PDF211.22 Responsibilities of quality control unit.
TEXT PDF211.25 Personnel qualifications.
TEXT PDF211.28 Personnel responsibilities.
TEXT PDF211.34 Consultants.
TEXT PDF211.42 Design and construction features.
TEXT PDF211.44 Lighting.
TEXT PDF211.46 Ventilation, air filtration, air heating and cooling.
TEXT PDF211.48 Plumbing.
TEXT PDF211.50 Sewage and refuse.
TEXT PDF211.52 Washing and toilet facilities.
TEXT PDF211.56 Sanitation.
TEXT PDF211.58 Maintenance.
TEXT PDF211.63 Equipment design, size, and location.
TEXT PDF211.65 Equipment construction.
TEXT PDF211.67 Equipment cleaning and maintenance.
TEXT PDF211.68 Automatic, mechanical, and electronic equipment.
TEXT PDF211.72 Filters.
TEXT PDF211.80 General requirements.
TEXT PDF211.82 Receipt and storage of untested components, drug product containers, and closures.
TEXT PDF211.84 Testing and approval or rejection of components, drug product containers, and closures.
TEXT PDF211.86 Use of approved components, drug product containers, and closures.
TEXT PDF211.87 Retesting of approved components, drug product containers, and closures.
TEXT PDF211.89 Rejected components, drug product containers, and closures.
TEXT PDF211.94 Drug product containers and closures.
TEXT PDF211.100 Written procedures; deviations.
TEXT PDF211.101 Charge-in of components.
TEXT PDF211.103 Calculation of yield.
TEXT PDF211.105 Equipment identification.
TEXT PDF211.110 Sampling and testing of in-process materials and drug products.
TEXT PDF211.111 Time limitations on production.
TEXT PDF211.113 Control of microbiological contamination.
TEXT PDF211.115 Reprocessing.
TEXT PDF211.122 Materials examination and usage criteria.
TEXT PDF211.125 Labeling issuance.
TEXT PDF211.130 Packaging and labeling operations.
TEXT PDF211.132 Tamper-evident packaging requirements for over-the-counter (OTC) human drug products.
TEXT PDF211.134 Drug product inspection.
TEXT PDF211.137 Expiration dating.
TEXT PDF211.142 Warehousing procedures.
TEXT PDF211.150 Distribution procedures.
TEXT PDF211.160 General requirements.
TEXT PDF211.165 Testing and release for distribution.
TEXT PDF211.166 Stability testing.
TEXT PDF211.167 Special testing requirements.
TEXT PDF211.170 Reserve samples.
TEXT PDF211.173 Laboratory animals.
TEXT PDF211.176 Penicillin contamination.
TEXT PDF211.180 General requirements.
TEXT PDF211.182 Equipment cleaning and use log.
TEXT PDF211.184 Component, drug product container, closure, and labeling records.
TEXT PDF211.186 Master production and control records.
TEXT PDF211.188 Batch production and control records.
TEXT PDF211.192 Production record review.
TEXT PDF211.194 Laboratory records.
TEXT PDF211.196 Distribution records.
TEXT PDF211.198 Complaint files.
TEXT PDF211.204 Returned drug products.
TEXT PDF211.208 Drug product salvaging.

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