21 CFR
Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
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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
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Clause
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A. General Provisions
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B. Organization & Personnel
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211.22 Responsibilities of Quality control unit
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211.25 Personnel Qualifications
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211.28 Personnel Responsibilities
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211.34 Consultants
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C. Building & Facilities
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211.42 Design and construction features
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211.44 Lighting
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211.46 Ventilation, air filtration, air heating and cooling
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211.48 Plumbing
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211.50 Sewage and refuse
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211.52 Washing and toilet facilities
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211.56 Sanitation
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211.58 Maintenance
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D. Equipment
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211.63 Equipment design, size and location
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211.65 Equipment construction
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211.67 Equipment cleaning and maintenance
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211.68 Automatic, mechanical and electronic equipment
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211.72 Filters
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E. Control of components and Drug product containers and
closures
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211.80 General requirements
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211.82 Receipt and storage of untested components, drug
product containers and closures
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211.84 Testing and approval or rejection of components, drug
product containers and closures
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211.86 Use of approved components, drug product containers and
closures
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211.87 Retesting of approved components, drug product
containers and closures
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211.89 Rejected components, drug product containers and
closures
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211.94 Drug product containers and closures
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F. Production & Process Control
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211.100 Written procedures; deviations
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211.101 Charge-in of components
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211.103 Calculation of yield
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211.105 Equipment identification
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211.110 Sampling and testing of in-process materials and drug
products
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211.111 Time limitations on production
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211.113 Control of microbiological contamination
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211.115 Reprocessing
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G. Packaging & labeling Control
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211.122 Materials examination and usage criteria
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211.125 Labeling issuance
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211.130 Packaging and labeling operations
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211.132 Tamper evident packaging requirements for over the
counter (OTC) human drug products
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211.134 Drug product inspection
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211.137 Expiration Dating
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H. Holding & distribution
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211.142 Warehousing procedures
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211.150 Distribution procedures
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I. Laboratory Controls
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211.160 General requirements
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211.165 Testing and release for distribution
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211.166 Stability testing
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211.167 Special testing requirements
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211.170 Reserve samples
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211.173 Laboratory animals
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211.176 Penicillin contamination
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J. Records & reports
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211.180 General requirements.
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211.182 Equipment
cleaning and use log
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211.184 Component, drug product container, closure, and
labeling records
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211.186 Master production and control records
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211.188 Batch production and control records
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211.192 Production record review
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211.194 Laboratory records
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211.196 Distribution records
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211.198 Complaint files
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K. Returned and salvaged drug products
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211.204 Returned drug products
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211.208 Drug product salvaging
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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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