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21 CFR 11, 58, 210/211, 600, 601, 610, 820 - Multi-US GMPs

21 CFR 11, 58, 210/211, 600, 601, 610, 820 - Multi-US GMPs

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Multi-US GMPs

US FDA Title 21 CFR Parts:

  • Part 11 - Electronic Records/Electronic Signatures (ERES) with Scope and Application
  • Part 58 - Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies
  • Part 210/211 - GMP in Manufacturing, Processing, Packaging or Holding of Drugs and Finished Pharmaceuticals
  • Part 600 - Biological Products: General
  • Part 601 - Licensing Biologics
  • Part 610 - General Biological Products Standards
  • Part 820 - Quality Systems Regulations
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