ISPE, a global not-for-profit association of 22,000 pharmaceutical science and manufacturing professionals, announced that it has released a new guidance document on pharmaceutical commissioning and qualification entitled, ISPE Good Practice Guide: Applied Risk Management in Commissioning and Qualification. This new Guide successfully provides a bridge between the baseline strategies outlined in the ISPE Baseline® Guide, Volume 5: Commissioning and Qualification and the more advanced strategies prescribed in the ISPE Guide: Science- and Risk-Based Approach for the Delivery of Facilities, Systems, and Equipment.

“With the rapid changes currently underway in the pharmaceutical industry, it’s becoming more and more common to find companies at all points of the continuum when it comes to commissioning and qualification best practices,” said Steve Wisniewski, one of the Guide’s authors. “ISPE recognized the necessity of having available guidance to answer questions across the entire spectrum from Baseline to full ICH Q8, Q9, and Q10 adaptation. 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.”

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.

In a further effort to assist companies in transitioning 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. The 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. By including the Appendix, ISPE hopes to provide an additional value to those purchasing the Baseline Guide Volume 5 by showing an updated approach to impact assessments.
The ISPE Good Practice Guide: Applied Risk Management in Commissioning and Qualification was launched as part of the ISPE Brussels Conference, which took place in September in Brussels, Belgium. Educational content related to the Guide also will be featured at the 2011 ISPE Annual Meeting, taking place November 6-9, 2011 in Grapevine, TX.

For more information on the ISPE Good Practice Guide: Applied Risk Management in Commissioning and Qualification, or to order a copy in either bound or electronic form, visit www.ispe.org/ispe-good-practice-guides/applied-risk-management-cq.