In 1962, the US government told the FDA to make sure that all medicines are manufactured using good manufacturing practices (GMP) which should be compliant to FDA 21 CFR Part 210 and 21 CFR 211. This was because there were worries about some medicines being made in a bad way, like when a medicine called thalidomide caused birth defects. The 1962 Drug Amendments brought cGMP, modern quality assurance and control control guideline to drug manufacturing to make sure medicines are safe and high quality.
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
Also Read : 21 CFR Part 210 – cGMP in Manufacturing, Processing, Packing, or Holding of Drugs; General