An academic perspective: Knowledge management: The orphan enabler— enabling ICH Q10 implementation

Nuala Calnan, Anne Greene, Paige E. Kane

Research output: Chapter in Book/Report/Conference proceedingChapterpeer-review

Abstract

Despite the fact that the ICH Q10 Pharmaceutical Quality System guideline has been with us since 2008, the transformation of the traditional Quality Management Systems (QMS) in use within the pharmaceutical industry into an effective Pharmaceutical Quality Systems (PQSs) remains a work in progress. This chapter focuses on understanding the implementation essentials necessary to deliver an “effective quality management system for the pharmaceutical industry” [Introduction, ICH Q10 p. 1] 1 and the crucial role that knowledge management plays.

Original languageEnglish
Title of host publicationA Lifecycle Approach to Knowledge Excellence in the Biopharmaceutical Industry
PublisherCRC Press
Pages133-152
Number of pages20
ISBN (Electronic)9781498750486
ISBN (Print)9781498750479
DOIs
Publication statusPublished - 1 Jan 2017

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