Unlocking the Knowledge: The Key to Delivering the Compliance and Business Benefits Outlined in ICH Q10 for Medicinal Product Manufacture

Nuala Calnan

doi:10.21427/z9rh-q530

Unlocking the Knowledge: The Key to Delivering the Compliance and Business Benefits Outlined in ICH Q10 for Medicinal Product Manufacture

Nuala Calnan

Graduate Business School

Research output: Contribution to conference › Paper › peer-review

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

Original language	English
DOIs	https://doi.org/10.21427/z9rh-q530
Publication status	Published - 2012
Event	ISPE Annual Meeting - San Francisco, United States Duration: 1 Jan 2012 → …

Conference

Conference	ISPE Annual Meeting
Country/Territory	United States
City	San Francisco
Period	1/01/12 → …

Keywords

Pharmaceutical Quality System
Operational Excellence
Lean
Six Sigma
knowledge management
Regulatory Drivers
Regulatory Actions

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10.21427/z9rh-q530Licence: CC BY-NC-SA

Cite this

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AB - 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

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KW - Operational Excellence

KW - Lean

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KW - knowledge management

KW - Regulatory Drivers

KW - Regulatory Actions

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Unlocking the Knowledge: The Key to Delivering the Compliance and Business Benefits Outlined in ICH Q10 for Medicinal Product Manufacture

Abstract

Conference

Keywords

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