New ICH Q3D Training Materials available
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
Related GMP News
12.03.2025EMA publishes Considerations regarding the Implementation of ICH M13A on Bioequivalence
12.03.2025Proposed Update to USP <1058> on Analytical Instrument and System Qualification
06.03.2025Eurachem publishes Leaflet on Analytical Equipment and Systems
06.03.2025Further Modifications to USP Chapter <621> Chromatography Published for Comment
26.02.2025FDA Warning Letter Highlights Responsibilities of Contract Testing Laboratories
26.02.2025New ISO/TR 33402:2025 on Reference Material Preparation