21 CFR Part 210 & 211 Quality Assurance

21 CFR Part 210 and 211

21 CFR Part 210 deals with the Manufacturing, Processing, Packaging or  Holding of drugs, while CFR Part 211 deals with finished pharmaceuticals. This cGMP Guidance related to the pharmaceutical and drug-related industry.

FDA 21 CFR Part 210 & 211:

The move was in response to concerns about substandard drug manufacturing practices at the time.

The 1962 Drug modification brought modern quality assurance and control principles to drug manufacturing.

The word “current” was later added to make it “CGMP” (or cGMP) to imply that the regulation allows for changing technology in attaining GMP.

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FDA 21 CFR Part 210 and 211:

CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS

  • Subpart A–General Provisions.
  • Subpart B–Organization and Personnel.
  • Subpart C–Buildings and Facilities.
  • Subpart D–Equipment.
  • Subpart E–Control of Components and Drug Product Containers and Closures.
  • Subpart F–Production and Process Controls.
  • Subpart G– Packaging and Labeling Control
  • Subpart H– Distribution and Holding.
  • Subpart I–Laboratory Controls.
  • Subpart J– Reports and Records.
  • Subpart K–Returned and Salvaged Drug Products.