Exploring the Risk-Knowledge Infinity Cycle (RKI Cycle) across the Product Lifecycle
Case studies demonstrating the link between knowledge and risk in technology transfer and commercial manufacture
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.
The needs of patients must always be at the forefront of what we do. Many of our colleagues are taking on the challenge of rethinking the old ways. They are collaborating with each other and the regulatory agencies to take effective steps to remain at the forefront of regulatory science and...
The San Francisco Bay Area Chapter has won numerous ISPE Awards by virtue of their contributions to the pharmaceutical industry. They continue to have their finger on the pulse of the local industry and respond with innovative and educational programs. The Chapter’s Emerging Leaders Committee is...