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 issue of data integrity may appear archaic in a highly connected, digital world. Yet many within the pharmaceutical industry it continues – be it intentional or not – to fall foul of regulators tasked with auditing businesses’ practices. Peter Cusworth at Yokogawa examines an age-old problem,...
The wait is over… The 2021 ISPE Annual Meeting & Expo is back and will be held in Boston, Massachusetts, at the Hynes Convention Center and Sheraton hotel from 31 October–3 November. This year’s conference theme, ‘Agility. Collaboration. Innovation.’, truly represents how our industry has responded...
Featured in this edition of the Pharmaceutical Engineering Online Reading Roundup are the most read online articles during May 2021. Learn more about cleanliness classifications for facilities, steam sterilization, GAMP®, and more from what visitors to the PE Online site were reading last month