Since the publishing of ICH Q10, Quality Risk Management (QRM) and Knowledge Management (KM) have been positioned as dual enablers to an effective Pharmaceutical Quality System. While there is broad agreement QRM and KM are highly interdependent in principle, there is recognition they are not well integrated in practice, and better integration is an opportunity to better manage risk and thus, increase patient protection.
A framework, the Risk-Knowledge Infinity Cycle (RKI Cycle), has been developed as a result of a research study carried out in conjunction with TU Dublin, to better integrate QRM and Knowledge Management which can be applied across the entire product lifecycle. Details of the framework will be explored in an upcoming ISPE webinar, and application of the Risk-Knowledge Infinity Cycle Cycle to the Commercial Manufacturing and Technology Transfer lifecycle phases will be illustrated through multiple short case studies, including examples to demonstrate the benefits of effective tacit knowledge transfer. In addition, a re-imagined PQS foundation will presented, enabled by QRM and Knowledge Management as intentionally connected and synergistic practices, as a means to reduce risk and ultimately benefit patients.
