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22 Pharmaceutical Technology ® Regulating Innovation, Quality, and Risk eBook January 2024 PharmTech.com Qualit y Knowledge and KM across ICH and other regula- tory guidance. While ICH Q10 does not define the term "knowledge," the 2018 International Organization for Standardization (ISO) standard on KM, ISO 30401:2018, Knowledge Management Systems—Requirements provides a helpful definition of knowledge as: "Human or organizational asset enabling effective decisions and action in context" (11). The ISO definition is further clarified as follows: • "Knowledge can be individual, collective, or orga- nizational. • "There are diverse views on the scope covered within knowledge, based on context and purpose. The definition above is general as to the various perspectives. Examples of knowledge include in- sights and know-how. • "Knowledge is acquired through learning or expe- rience" (11). Regarding the term "knowledge management," ICH Q10 introduced the concept of KM and provided a defi- nition in 2008 as: "Knowledge management is a systematic ap- proach to acquiring, analysing, storing and dis- seminating information related to products, man- ufacturing processes and components" (5). It further stated that product and process knowl- edge should be managed throughout the product life- cycle and includes examples of sources of knowledge: "Sources of knowledge include, but are not limited to, prior knowledge (public domain or internally documented); pharmaceutical development studies; technology transfer activities; process validation studies over the product lifecycle; manufacturing experi- ence; innovation; continual improvement; and change management activities" (5). It is in ICH Q10 that QRM and KM were linked as the dual enablers for an effective PQS by "providing the means for science- and risk-based decisions related to product quality" (5). It is worth noting that while ICH Q10 provided a definition of KM, it does this without any references to KM in the literature, or by discussing KM guidance in other industries. In addition to ICH Q10, there are many other direct and indirect references to knowledge and KM across ICH quality guidelines, including ICH Q8(R2), ICH Q8/ Q9/Q10 Questions & Answers, ICH Q11, and ICH Q12, as well as in other regulatory guidance issued by the World Health Organization (WHO), EudraLex in the European Union, and Pharmaceutical Inspection Co-operation Scheme (PIC/S), which have previously been reviewed in detail by the authors in 2020 (12). Furthermore, since the 2020 review, references to the role of knowledge and KM are also included in ICH Q13, Continuous Processing of Drug Substances and Drug Products (13), ICH Q14, Ana- lytical Procedure Development (14), and further in FDA's pharmaceutical quality initiative, known as knowl- edge-aided assessment and structured applications (KASA) (15). Consider i ng reg u lator y g uida nce ta ken i n ag- gregate, wh i le it is ICH Q10 t hat def ined KM in 2008, it is heartening to see the concepts of knowl- edge and KM emerging and repeatedly reinforced in the interceding 15 years. Indeed, a closer look at the recent ICH Q 9(R1) extends this theme and pro- vides an opportunity for risk and knowledge to be intentionally connected. A closer look: the emergence of knowledge man- agement in ICH Q9(R1). The concept paper for ICH Q9(R1) (3) identified four primary areas for improvement in the practice of QRM, for both pharma companies and regulatory authorities as follows: • High levels of subjectivity in risk assessments and in QRM outputs • Supply and product availability risks • Lack of understanding as to what constitutes for- mality in QRM • Lack of clarity and understanding on risk-based decision-making. Furthermore, two additional points were raised in the concept paper to be addressed, namely: • Expectations for risk review • Emphasis on "hazard identification" (rather than "risk identification"). Collectively these six areas of focus are referred to as the "revision topics." While knowledge-related or KM-related areas for improvement were not identified in the concept paper directly (i.e., as one of the six revision topics), a closer look at the revised ICH Q9(R1) guideline reveals that the concepts of both "knowledge" and "knowledge manage- ment" have a significant presence. This is demonstrated by an evaluation carried out by the authors, presented in Table I as a summary of the frequency of the use of each team in the original ICH Q9 guideline, and in the revised ICH Q9(R1) guideline. While the term "knowledge management" is not as prevalent as "knowledge" there is a significant change TABLE I. Frequency of "knowledge" and "knowledge management" in ICH Q9(R1). Term frequency ICH Q9 (2005) ICH Q9(R1) (2023) "knowledge" 11 23 "knowledge management" 0 3