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News about GMP/cGMP


Training Presentation to ICH Q11 Draft Q&A

The ICH (International Council for Harmonisation) has developed a training presentation on the ICH Q11 Q&A document Selection & Justification of Starting Materials. Therein the Expert Working Group gives answers to the following questions:


  • Why is the Q&A document needed now?
  • What is the perceived problem?
  • What are the implications of the document?
  • What is the scope relative to the parent guideline?
  • What general principles have to be considered on Section 5.1.1 Selection of Starting Materials for Synthetic Drug Substances and Section 5.2.1 Justification of SM selection for synthetic drug substances?
  • What are the main issues that need to be resolved?
  • What are the potential benefits from further guidance?
  • What additional guidance is provided?
  • What is the current state of the document?

Click here for direct access to the PowerPoint Presentation.


ICH: Newsroom

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Literature recommendation
ICH Q8, Q9, Q10
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