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Abstract

While the authors have published widely on the need to unite the twin enablers of ICH Q10 [1], quality risk management (QRM) and knowledge management (KM), how to integrate QRM and KM in practice has proven to be quite challenging. QRM and KM are wide-ranging activities that impact many elements of pharmaceutical manufacturing and regulation. Pharmaceutical manufacturers and their regulators work to apply risk-based approaches to their work and strive to use knowledge in a smart and efficient way, but so far, in the experience of the authors, it has proven difficult to get these things right.

One way to consider how to operationalise QRM and KM is in the context of demonstrating the effectiveness of one’s pharmaceutical quality system (PQS). In a highly effective PQS, quality risk management activities are informed by existing knowledge, new knowledge is an output from quality risk management activities, and risks to product quality and patients are effectively managed in a proactive way. This is perhaps the essence of ICH Q10, and as this ICH guideline from 2008 indicates, when pharmaceutical companies demonstrate the effectiveness of their PQS and the accompanying application of ICH Q8/Q9/Q10, there are many potential science-based opportunities for regulatory relief that companies may acquire. The recent revision of ICH Q9, now ICH Q9(R1) [2], provided substantial new guidance in relation to knowledge-driven QRM activities, and there is now a clear path forward for realising such opportunities.

DOI

https://doi.org/10.21427/tr3d-cd82

Creative Commons License

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

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