Document Type

Article

Rights

This item is available under a Creative Commons License for non-commercial use only

Disciplines

Pharmacology and pharmacy

Abstract

An organization that effectively manages knowledge should be able to recognize and proactively apply new learnings to better anticipate risks. This is particularly important in the manufacture of medicinal products. Since the publication of ICH Q10 in 2010, Quality Risk Management (QRM) and Knowledge Management (KM) have been positioned as co-enablers to the Pharmaceutical Quality System. The authors of this paper present a Knowledge Management process model to foster greater practical understanding of the practice of knowledge management. This model when joined with the familiar ICH Q9 process model for QRM, should enable a company to better manage their knowledge and risk. In addition, a framework, the Risk-Knowledge Infinity Cycle is presented to better link these two disciplines at large and specifically as the dual enablers to ICH Q10. It is the authors belief that treating QRM and KM in this way will have a variety of potential benefits for biopharmaceutical companies, including improved risk-based decision making, facilitating evidence-based risk reduction and increased process knowledge, leading to less uncertainty and subjectivity in QRM outputs. This should ultimately result in more effective risk-based control strategies and more reliable manufacturing processes, which potentially lead to increased protection - and other benefits including product availability and value - for patients. This paper presents the Knowledge Management process model, and the Risk-Knowledge Infinity Cycle and an example of the application of the Risk-Knowledge Infinity Cycle.

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