ISPE Good Practice Guide: Applied Risk Management for Commissioning and Qualification

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Guidance Documents

Published: October 2011
Pages: 140
Table of Contents ( Adobe PDF 405 KB)

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The ISPE Good Practice Guide: Applied Risk Management in Commissioning and Qualification describes how organizations can move from established baseline practice to a more efficient science- and risk-based framework. It illustrates the application of Quality Risk Management to traditional commissioning and qualification practices, linking traditional terminology and approaches to the newer science- and risk-based specification and verification terminology and approaches applied in ICH Q8, Q9, and Q10, ASTM E2500, and ISPE Guide: Science and Risk-Based Approach for the Delivery of Facilities, Systems and Equipment.

The approach described in the ISPE Good Practice Guide: Applied Risk Management in Commissioning and Qualification allows companies to achieve the benefits of a science- and risk-based model by outlining bridging strategies for organizations with well-established qualification-based Quality Management Systems and providing a roadmap showing the spectrum of potential approaches for this transition.

Mapping Document for ISPE Specification and Verification Guides

This free document explains the relationship between the following ISPE Guides.

ISPE Baseline Guide, Volume 5: Commissioning and Qualification (Baseline Guide Volume 5)
ISPE Guide: Science and Risk-Based Approach for the Delivery of Facilities, Systems, and Equipment (FSE Guide)
ISPE Good Practice Guide: Applied Risk Management in Commissioning and Qualification (Applied Risk Management Guide)