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International Regulatory Guidance

Food and Drug Administration (FDA) Guidelines

  • Characterization and qualification of cell substrates and other biological starting materials used in the production of viral vaccines for the prevention and treatment of infectious diseases.(2010 guidance
  • Content and review of chemistry, manufacturing and control information for human gene therapy investigational new drug applications.(2004 – draft guidance)
  • Monoclonal antibodies used as reagents in drug manufacture. (2001 guidance
  • Points to consider in the manufacture and testing of monoclonal antibody products for human use. (1997 guidance
  • Points to consider in the characterization of cell lines used to produce biologicals. (1993 guidance)
  • Points to consider in the production and testing of new drugs and biologicals produced by recombinant DNA technology. (guidance 1985)
  • US Code of Federal Regulations  21 CFR 610.12 (Sterility)
  • US Code of Federal Regulations  21 CFR 610.30 (Mycoplasma)
  • United States Pharmacopeia (USP) Chapter <63> monograph (Mycoplasma Tests)
  • United States Pharmacopeia (USP 24 Microbiological Tests)

International Conference on Harmonisation (ICH) Guidelines

  • Q5A : Viral safety of biotechnology products derived from cell lines of human or animal origin.(guidance 1998)
  • Q5D : Derivation and characterisation of cell substrates used for production of biotechnological/biological products. (guidance 1997)

World Health Organisation (WHO) Guidelines

  • Recommendations for the evaluation of animal cell cultures as substrates for the manufacture of biological medicinal products and the characterization of cell banks. (guidance 2009)

 European Medicines Agency (EMEA) Guidelines

  • European Pharmacopeia 2.6.1 Sterility
  • European Pharmacopoeia 2.6.2  Mycobacteria
  • European Pharmacopoeia 2.6.7 Mycoplasmas
  • European Pharmacopoeia 2.6.16. Tests for extraneous agents in viral vaccines for human use.

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Printed from http://www.moredun.org.uk/moredun-scientific-homepage/biosafety-testing/regulatory-guidance on 27/05/17 09:14:35 AM

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