TY - JOUR T1 - Knowledge Management as a Pharmaceutical Quality System Enabler: How Enhanced Knowledge Transfer can help close the Q10 to Q12 Gap JF - PDA Journal of Pharmaceutical Science and Technology JO - PDA J Pharm Sci Technol DO - 10.5731/pdajpst.2020.011825 SP - pdajpst.2020.011825 AU - Martin J Lipa AU - Anne Greene AU - Nuala Calnan Y1 - 2020/01/01 UR - http://journal.pda.org/content/early/2020/07/16/pdajpst.2020.011825.abstract N2 - Knowledge Management (KM) is identified in ICH Q10, Pharmaceutical Quality System, as a key enabler to the Pharmaceutical Quality System (PQS). ICH Q8 (Pharmaceutical Development) ICH Q11, (Development and Manufacture of Drug Substances) and ICH Q12 (Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management) each build on the expectation for knowledge to be managed effectively in order to support and improve the product and process across the Pharmaceutical Product Lifecycle. However, in spite of the fact that KM was introduced in ICH Q10 over 10 years ago, there is ample evidence that it is not yet a mature discipline within the biopharmaceutical sector and the authors suggest this could hinder full realization of the potential benefits of ICH Q8, ICH Q11 and ICH Q12. The Pharmaceutical Regulatory Science Team (PRST), a research team based at the Dublin Technological University (TU Dublin) in Ireland, has been conducting research on KM for several years, and this paper presents the next phase in this research. Specifically, the focus of this current research is to explore ways to offer practical solutions to improve the management of knowledge across the Pharmaceutical Product Lifecycle, starting with a focus on enhancing knowledge transfer during technology transfer projects. Typical challenges associated with ineffective knowledge transfer are presented and the high-level requirements need to address these were identified through the research. From these requirements, a four-step framework was developed as a systematic means to enhance knowledge transfer. Accompanying the framework is a KM toolkit consisting of a range of KM practices (tools, processes and behaviors) to facilitate more effective knowledge flow during technology transfer. It is then illustrated how such a framework can be extended across the entire Pharmaceutical Product Lifecycle, supporting the advancement of KM from an Enabler in ICH Q10 to a Key Consideration (both technical and regulatory) in ICH Q12. ER -