In November 2020, a newly formed working group of the ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) published a concept paper [1] outlining the considerations for an update to ICH Q9: Quality Risk Management [2]. In the concept paper, the expert group identified four areas for improvement with respect to the current application of Quality Risk Management (QRM). One of the areas identified as problematic was a ‘lack of clarity in risk-based decision making’. The paper described a ‘lack of clarity on what good risk-based decisionmaking means’. This paper looks at risk-based decision-making and, in particular, whether higher level of formality in decision-making would improve the effectiveness of both QRM and KM within key elements Pharmceutical Quality System (PQS).



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This work is licensed under a Creative Commons Attribution-NonCommercial-Share Alike 4.0 International License.



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