US FDA 21 CFR 211 & 21 CFR 210

CFR Part 210 deals with the Manufacturing, Processing and Buildings of drugs, During CFR Part 211 deals with finished pharmaceuticals .These cGMP Guidance Things the pharmaceutical and drug-related industry.

FDA 21 CFR Part 11

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– Labeling Control and Packaging.
  • Subpart H– Distribution and Holding.
  • Subpart I–Laboratory Controls.
  • Subpart J– Reports and Records.
  • Subpart K–Returned and Salvaged Drug Products

FDA 21 CFR Part 210-211:

The move was in response to concerns about substandard drug manufacturing practices at the time, such as the use of thalidomide, a drug used in Europe to treat morning sickness, which was found to cause birth defects.

The 1962 Drug modification Bring 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.

Related Projects:

GMP-Guideline

Name: GMP Guideline
Year: 2003
Type: Got it

ISO 15378 Consultant

Name: Quality Assurance ISO 15378
Year: 2001
Type: Got it

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