Wednesday 4 December 2019

21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals





21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals

FDA ensures the quality of drug products by carefully monitoring drug manufacturers' compliance with its Current Good Manufacturing Practice (CGMP) regulations.  The CGMP regulations for drugs contain minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product.  The regulations make sure that a product is safe for use, and that it has the ingredients and strength it claims to have.
Code of Federal Regulations (CFR).  FDA's portion of the CFR is in Title 21, which interprets the Federal Food, Drug and Cosmetic Act and related statutes, including the Public Health Service Act.
  • 21 CFR Part 314 and Part 600 - Application and licensing submission requirements for new and generic drug applicants.
  • 21 CFR Part 210 - Current Good Manufacturing Practice in Manufacturing Processing, packing, or Holding of Drugs.
  • 21 CFR Part 211- Current Good Manufacturing Practice for Finished Pharmaceuticals.
21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals

Subpart
Clause
A. General Provisions
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B. Organization & Personnel
211.22 Responsibilities of Quality control unit
211.25 Personnel Qualifications
211.28 Personnel Responsibilities
211.34 Consultants
C. Building  & 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
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
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
F. Production & Process Control
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
G. Packaging & 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
H. Holding & distribution
211.142 Warehousing procedures
211.150 Distribution procedures
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
J. Records & 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
K. Returned and salvaged drug products
211.204 Returned drug products
211.208 Drug product salvaging

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1 comment:

  1. During the FDA inspection it was discovered that electronic records are used to establish portions of your design output, 21 CFR 820.30(d) The requirements of 21 CFR Part 11 are designed to ensure that electronic records are trustworthy, reliable, and generally equivalent to paper records

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