Open Access. Powered by Scholars. Published by Universities.®
Pharmacy Administration, Policy and Regulation Commons™
Open Access. Powered by Scholars. Published by Universities.®
- Discipline
Articles 1 - 3 of 3
Full-Text Articles in Pharmacy Administration, Policy and Regulation
“Holistic Risk-Based Site Surveillance – A Data-Based Approach To Site Quality Risk Identification And Assessment In The Pharmaceutical Industry”, Matteo Bernasconi, Thomas Friedli, Nuala Calnan (Editor)
“Holistic Risk-Based Site Surveillance – A Data-Based Approach To Site Quality Risk Identification And Assessment In The Pharmaceutical Industry”, Matteo Bernasconi, Thomas Friedli, Nuala Calnan (Editor)
Level 3
Effective quality risk management is fundamental in guaranteeing the development and manufacture of high-quality drugs, reducing drug shortages, and avoiding harm to patients’ health. The ability to accurately assess the actual risk environment, predict potential product quality or supply disruption issues and act to eliminate, prevent, reduce or mitigate them is key to improvements in quality management maturity. This paper illustrates a just-launched research project aimed at developing a comprehensive framework for how to assess and predict risks by leveraging a range of diverse factors.
A Survey Report On The Current State Of Quality Risk Management (Qrm) And Knowledge Management (Km) Integration, Martin Lipa, Kevin O'Donnell, Anne Greene
A Survey Report On The Current State Of Quality Risk Management (Qrm) And Knowledge Management (Km) Integration, Martin Lipa, Kevin O'Donnell, Anne Greene
Level 3
As part of research to better define and improve the integration between quality risk management (QRM) and knowledge management (KM) as dual enablers of an effective pharmaceutical quality system, a survey was conducted in February 2021 to explore this relationship. The survey explored the current state relationship in theory and in practice, solicited feedback on a proposed framework, the Risk-Knowledge Infinity Cycle, to improve the connection between QRM and KM, associated benefits and potential actions to make progress in this regard. The results suggest QRM and KM are highly interdependent in theory but much less so in practice. Further, …
Mapping Km Methods And Tools Across The Pharmaceutical Product Lifecycle, Martin Lipa, Paige Kane
Mapping Km Methods And Tools Across The Pharmaceutical Product Lifecycle, Martin Lipa, Paige Kane
Level 3
Knowledge management is positioned as an enabler of ICH Q10, and the visibility and availability of product and process knowledge across the entire pharmaceutical product lifecycle is vital to the sustained success of an organization and to the effectiveness of an organization’s pharmaceutical quality system as defined by ICH Q10. This paper illustrates where knowledge management has a role to play within each product lifecycle phase. This paper goes on to further define phase-appropriate KM methods and tools to help address these needs and create end-to-end product and process knowledge visibility and availability.