ISPE IGPGARMCQUS

$49.00

ISPE Good Practice Guide: Applied Risk Management for Commissioning and QualificationInternational Society for Pharmaceutical Engineering / 2011 / 140 pages

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.




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  • Model: 6AD3PB95
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This product was added to our catalog on Thursday 01 January, 1970.

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