21 CFR Part 210 and 211 Quality Assurance

In the 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.

21 CFR Part 210 and 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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To Apply For FDA 21 CFR Part 210 and 211 QMS For Your Product

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.

 

Operon Strategist helps in maintaining compliance with 21 CFR 210 and 211 which is critical to the pharmaceutical industry. This includes observation of current good manufacturing practice (cGMP) by understanding and planning the processes and methods defined in FDA Guidelines. We also help in the development of training modules for comprehension to various parts of the regulations, and also in the guide in strategic review and assessment of the organization for personal optimization.
We also help our client In-depth system audits and recommendations for improvements, site inspection preparation activities and mock inspections.