Provide PDF Format
ISPE Good Practice Guide: Applied Risk Management for Commissioning and Qualification
- Secure PDF Files
- Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 10/01/2011
- Publisher: ISPE
$225.00$450.00
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.
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.
Related Products
GAMP Good Practice Guide: Manufacturing Execution Systems - A Strategic and Program Management Approach
Secure PDF Files..
$225.00 $450.00
GAMP Good Practice Guide: Calibration Management
Customers Who Bought This Also Bought..
$52.00 $103.00
ISPE Good Practice Guide: Heating, Ventilation, and Air Conditioning (HVAC)
Secure PDF Files..
$225.00 $450.00