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Implementation of ICH Q3D in Product Development

pdf fileHarris L;

Presentation by Dr. Laurence. J. Harris (Lhasa Elemental Impurities consortium member and Pfizer Colleague) at the 3rd Annual Impurities: Genotoxic and Beyond
Summit, 12 - 13 June 2019, Munich, Germany.

 

  • ICH Q3D background knowledge.
  • Implementation.
    • tools developed to support implementation;
      • flexible procedural guidance.
      • risk assessment template.
      • template for submission of the risk assessment summary.
      • fit for purpose analytical methodology.
  • Excipients.
  • Using prior knowledge (data) to make the risk assessment process more efficient.
  • Case histories
    • example risk assessments
    • control strategies.
  • Conclusions / Learnings.
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