FDA

21 CFR,211

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


PART 211--CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED
PHARMACEUTICALS

 

211.1 Scope.
211.3 Definitions.
211.22 Responsibilities of quality control unit.
211.25 Personnel qualifications.
211.28 Personnel responsibilities.
211.34 Consultants.
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.
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.
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.
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.
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.
211.142 Warehousing procedures.
211.150 Distribution procedures.
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.
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.
211.204 Returned drug products.
211.208 Drug product salvaging.
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21CFR, part 210
Title 21--Food and Drugs

CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND
HUMAN SERVICES
PART 210--CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING,
PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL

210.1 Status of current good manufacturing practice regulations.
210.2 Applicability of current good manufacturing practice regulations.
210.3 Definitions.

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21CFR, part 820
Title 21--Food and Drugs

CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND
HUMAN SERVICES
PART 820--QUALITY SYSTEM REGULATION

820.1 Scope.
820.3 Definitions.
820.5 Quality system.
820.20 Management responsibility.
820.22 Quality audit.
820.25 Personnel.
820.30 Design controls.
820.40 Document controls.
820.50 Purchasing controls.
820.60 Identification.
820.65 Traceability.
820.70 Production and process controls.
820.72 Inspection, measuring, and test equipment.
820.75 Process validation.
820.80 Receiving, in-process, and finished device acceptance.
820.86 Acceptance status.
820.90 Nonconforming product.
820.100 Corrective and preventive action.
820.120 Device labeling.
820.130 Device packaging.
820.140 Handling.
820.150 Storage.
820.160 Distribution.
820.170 Installation.
820.180 General requirements.
820.181 Device master record.
820.184 Device history record.
820.186 Quality system record.
820.198 Complaint files.
820.200 Servicing.
820.250 Statistical techniques

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