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Current Good Manufacturing Practice - Fda CGMP
Current Good Manufacturing Practice - Fda CGMP
PART 110
CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR
HOLDING HUMAN FOOD
Part 111
CURRENT GOOD MANUFACTURING PRACTICE FOR DIETARY SUPPLEMENTS
PART 211
CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS
PART 210
CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING,
PACKING, OR HOLDING OF DRUGS; GENERAL
PART 820
QUALITY SYSTEM REGULATION
Part 225
CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS
Part 226
CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED
Part 600
BIOLOGICAL PRODUCTS: GENERAL
Part 606
CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD
COMPONENTS
Part 610
GENERAL BIOLOGICAL PRODUCTS STANDARDS
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.
Current Good Manufacturing Practice - FDA cGMP
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.
Current Good Manufacturing Practice - FDA cGMP
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.