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After publishing the ICH Guidelines Q8, Q9, Q10 and Q11 there were various interpretations within and outside the ICH regions. Based on that experience the organisation decided to establish a working group to elaborate training materials for its ICH Q3D Guideline on "Elemental Impurities".
Now the ICH has issued some new materials on its website. This latest publication is a presentation with audio comments, prepared by the ICH Q3D Experts Working Group and presented by Dr John Kauffmann (FDA) Rapporteur. Please see the ICH website for the audio presentation file
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