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 language | English |
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Title of host publication | A Lifecycle Approach to Knowledge Excellence in the Biopharmaceutical Industry |
Publisher | CRC Press |
Pages | 133-152 |
Number of pages | 20 |
ISBN (Electronic) | 9781498750486 |
ISBN (Print) | 9781498750479 |
DOIs | |
Publication status | Published - 1 Jan 2017 |