ISPE expands commissioning and qualification guidance
Describes how to move from established baseline practice to a science- and risk-based framework
ISPE, the International Society for Pharmaceutical Engineering based in the US, has released new guidance on pharmaceutical commissioning and qualification.
The document, ISPE Good Practice Guide: Applied Risk Management in Commissioning and Qualification, bridges the basic strategies outlined in the ISPE Baseline Guide, Volume 5: Commissioning and Qualification and the more advanced strategies described in the ISPE Guide: Science- and Risk-Based Approach for the Delivery of Facilities, Systems, and Equipment.
‘While the ISPE Baseline Guide, Volume 5 remains relevant and is still a viable option, the ISPE Good Practice Guide: Applied Risk Management in Commissioning and Qualification serves as an excellent resource for companies that would like to incorporate some elements of Q8, Q9, and Q10, but do not wish to move to full implementation at this time,’ said Steve Wisniewski, one of the Guide’s authors.
The new guidance describes how firms 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 guidance allows companies to achieve the benefits of a science- and risk-based model by outlining bridging strategies for firms with well-established qualification-based Quality Management Systems and providing a roadmap showing the spectrum of potential approaches for this transition.
In a further effort to assist companies in making the transition from traditional impact assessment-based qualification approaches to ICH Q9 QRM-based approaches found in ASTM E2500 and the ISPE Guide: Science- and Risk-Based Approach for the Delivery of Facilities, Systems, and Equipment Guide (FSE Guide), ISPE will now include Appendix 2 from the FSE Guide with purchases of the Baseline Volume 5 document.
This Appendix contains an update for use with the Commissioning and Qualification Impact Assessment Chapter of the Baseline Guide, based on the experiences of project teams and considers the benefits and application of science-based process understanding.
