Issue link: https://www.e-digitaleditions.com/i/1514991
PharmTech.com Regulating Innovation, Quality, and Risk eBook January 2024 Pharmaceutical Technology ® 23 Qualit y in the recognition of the centrality and importance of knowledge to support QRM. This is welcomed by the authors, given the nature of ICH Q9(R1) as a "targeted revision" with "limited and specific adjustments" (1). In fact, a review of the six revision topics could indeed suggest a dependency of each of these six revision top- ics on knowledge and/or knowledge management, as summarized in Table II. Knowledge as an invaluable commodity for risk management and decision making. A further litera- ture review by the authors in 2020 (12,16) explored the relationship between knowledge and risk—and knowl- edge management and risk management—in pharma- ceutical regulatory guidance and in other industries and organizations, including the National Aeronautics and Space Administration (NASA). A key assertion re- sulting from this review is that knowledge is both an input to and an output from QRM, thus highlighting the opportunity for QRM and KM to be thoughtfully and intentionally connected. Arguably, the authors suggest that emergence of the importance of knowledge and KM in ICH Q9(R1) is a log- ical evolution of the recognition of the foundational role each play in informing risk and improving risk-based decision-making, as is evident through a holistic review of the document as shown in Tables I and II. At the end of the day, the pharmaceutical indus- try is a knowledge industry(17) and, on a daily basis, formally and informally assesses risk and makes countless decisions—each of which should seek to ensure quality products and to protect the patient. Knowledge is an indispensable commodity necessary to make this happen effectively. With greater knowl- edge comes greater understanding. Greater under- standing leads to reduced uncertainty. Reduced un- certainty in turn informs risk management activities and ultimately risk-based decision-making. Knowl- edge, indeed, is the currency for managing risk—and managing such knowledge is a smart investment for benefitting patients. Exploring the practical connection between knowledge and risk The authors, having recognized the disconnect between QRM and KM in practice, turned to systems-thinking principles to explore the connections between risk and knowledge, and between QRM and KM, starting with an assessment of practice at the time. Current state connectivity of quality risk manage- ment and knowledge management. In 2021, the authors collected data through a survey (18), which reported that, while 96% of survey respondents believe QRM and KM are highly interdependent as concepts supporting the PQS (i.e., how connected should they be), no one believes they are fully integrated in practice today (0%), with 4% responding they are intentionally but not optimally con- nected, and 85% reporting they are only partially con- nected. These data are summarized in Figure 1. TABLE II. Mapping "knowledge" and "knowledge management" (KM) references to ICH Q9(R1) revision topics. QRM is quality risk management. PQS is pharmaceutical quality system. Revision topic Selected text advocating knowledge or KM (bold added for emphasis) (1) Subjectivity in QRM Q9(R1) §4.1 • "…maximizing use of relevant data and sources of knowledge" • "Adequate resources and knowledge are available" Product availability risks Q9(R1) Chapter 6 • "An effective PQS uses quality risk management and knowledge management to provide an early warning system" • "Approval and oversight of outsourced activities and material suppliers is informed by […] effective knowledge management" Formality in QRM Q9(R1) §5.1 • "Systematic approaches for acquiring, analysing, storing and disseminating scientific information are essential for generating knowledge, which in turn informs all quality risk management activities" • "Uncertainty may be reduced via effective knowledge management" Risk-based decision-making Q9(R1) §5.2 • "[RBDM approaches] address uncertainty through the use of knowledge, facilitating informed decisions" • "As all decision making relies on the use of knowledge, see ICH Q10 for guidance in relation to Knowledge Management" Risk review Q9(R1) §4.6 • "The output/results of the risk management process should be reviewed to take into account new knowledge and experience" Hazard identification Q9(R1) §4.3 • "Hazard identification is a systematic use of information to identify hazards referring to the risk question or problem description. Information [knowledge] can include historical data, theoretical analysis, informed opinions, and the concerns of stakeholders"