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

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Published: October 2011
Pages: 140
Table of Contents ( 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)
Last Update: 25 October 2013

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