.png "FDA 21 CFR PART 211 CGMP Guidelines for Pharmaceuticals in Telugu")
US FDA 21 CFR PART 211 CGMP Guidelines for Finished Pharmaceuticals in Telugu
పూర్తి గైడ్ లైన్స్ కొరకు ఈ క్రింది టైటిల్స్ పై క్లిక్ చేయండి.
21 CFR PART 211—CURRENT 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.
US FDA 21 CFR PART 211 CGMP Guidelines for Finished Pharmaceuticals in Telegu:
Code of Federal Regulations (CFR)
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.
US FDA 21 CFR PART 211 CGMP Guidelines for Finished Pharmaceuticals in Telegu:
