JVT

Managing Knowledge and Risk – A Literature Review on the Interdependency of QRM and KM as ICH Q10 Enablers

ABSTRACT Quality Risk Management (QRM) and Knowledge Management (KM) have been positioned as co-enablers to the Pharmaceutical Quality System since the 2010 issuance of ICH Q10.  Yet these disciplines have remained largely distinct and disconnected in practice.  This paper presents a two-part literature review on this topic.  First is a review of how other industries have connected risk management and knowledge management.  This is followed by a review of relevant biopharmaceutical industry regulatory guidance to explore expectations for how risk, risk management, knowledge...

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