Published: October 2011
|Formats||Member Price||Nonmember Price|
|Bound Version||$145 / €140||$455 / €400|
|Individual Download||$145 / €140||$455 / €400|
|Which format is right for me?|
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.
This free document explains the relationship between the following ISPE Guides.
Design Considerations for WFI Distillation Systems Part 4
Thursday, 26 May 2016 13.05
Direct Access to Quality Manufacturing Experts
Wednesday, 25 May 2016 13.05
Broadening Pharmaceutical Training Footprint in Europe
Tuesday, 24 May 2016 19.05