Knowledge as the Currency of Managing Risk

Editor’s Note: This article was peer reviewed by a member of Pharmaceutical Technology®’s Editorial Advisory Board and was previously published in the September 2023 issue.

The current International Council for Harmonisation (ICH) Q9(R1) Quality Risk Management (QRM) guideline is a targeted revision of the initial guidance issued in 2005, intended to address subjectivity, formality, risk-based decision-making, and other specific areas for improvement. While not a formally defined area for improvement, the revised guidance invokes many new references to “knowledge” and “knowledge management (KM)” in supporting improvement in QRM practice and, by extension, to the goals of an effective pharmaceutical quality system.

Recognizing that QRM and risk-based decision-making (RBDM) both depend on knowledge to be effective, it could be suggested that knowledge is the currency of managing risk. This paper presents research and perspectives on the opportunity to better connect risk and knowledge through improved integration of QRM and KM, including presenting several potential benefits of such integration. A framework is proposed, the Risk-Knowledge Infinity Cycle (RKI Cycle), which could be used to improve the connectivity of risk and knowledge along with preliminary and practical recommendations to operationalize the RKI Cycle. In addition, the paper invokes concepts of systems thinking in connecting QRM and KM as well as the opportunity to consider the role of knowledge and KM more holistically across the pharmaceutical business through application of a process classification framework.

Read this article in the Pharmaceutical Technology/Pharmaceutical Technology Europe Regulating Innovation, Quality, and Risk eBook

About the authors

Martin J. Lipa*, PhD, martin.lipa@prst.ie, is senior research fellow, Pharmaceutical Regulatory Science Team. Anne Greene, PhD, is professor, Technological University Dublin, and director, Pharmaceutical Regulatory Science Team.

*To whom all correspondences should be addressed.

Article details

Pharmaceutical Technology/Pharmaceutical Technology Europe Regulating Innovation, Quality, and Risk eBook
Issue 1
January 2024
Pages: 20-28