ICH: Publication of the Introductory Presentation on ICH Q9 (R1)
The ICH published a 29-page presentation on the revision of ICH Q9 on 14 March 2023. The guideline on quality risk management was published in January 2023 (we reported) and will come into force in July 2023.
The PowerPoint presentation answers the questions about the "how" and "why" of the revision of ICH Q9. It addresses:
- the importance of subjectivity and formality in QRM
- risks to product availability in the absence of QRM
- insufficient strategic tracking and consistency in risk-based decision making
- summaries of the guideline content and the results of the public consultation
- cross-references to ICH Q10
Overall, a comprehensive overview of the objectives and background of the ICH Q9 revision has been prepared by the Expert Group (EWG) based on the concept paper, the business plan, and the work plan laid down in 2020. Further training material has been announced. For more detailed information on the guideline, we refer to our news of December 2021.
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