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1.4 CHEMICAL SCIENCES, 3. MEDICAL AND HEALTH SCIENCES, 3.4 HEALTH BIOTECHNOLOGY
This paper presents the challenges of delivering a holistic approach to the Pharmaceutical Quality System (Q10) expectations for medicinal product manufacture. It reviews the key findings from the recent ‘Operational Excellence in the Pharmaceutical Industry’ St. Gallen Uni. benchmarking report and explores the theme of 'Knowledge as the Key'. It explores how can we utilise familiar OPEX, Lean/ Six Sigma tools to capture this knowledge and deliver the expectations and opportunities for ICH Q10 and discusses this researchers study in the area of knowledge management and operational excellence.
It also includes a review of both the Regulatory Drivers and recent Regulatory Actions
Calnan, N. Unlocking the Knowledge: The key to delivering the compliance and business benefits outlined in ICH Q10 for medicinal product manufacture. ISPE Annual Meeting 2012 San Francisco: Global GMP Solutions.