Document Type

Conference Paper

Rights

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

Disciplines

1.4 CHEMICAL SCIENCES, 3. MEDICAL AND HEALTH SCIENCES, 3.4 HEALTH BIOTECHNOLOGY

Publication Details

ISPE Annual Meeting 2012 San Francisco: Global GMP Solutions

Abstract

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

Share

COinS