ISPE Expands Commissioning and Qualification Guidance Series

New guide bridges gap between Baseline Guide and full ICH Q8, Q9, Q10 adaptation

Published: Monday, December 12, 2011 - 10:15

(ISPE: Tampa, FL) -- The International Society for Pharmaceutical Engineering (ISPE), a global nonprofit association of 22,000 pharmaceutical science and manufacturing professionals, has released a new guidance document on pharmaceutical commissioning and qualification titled, ISPE Good Practice Guide: Applied Risk Management for 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,” says Steve Wisniewski, one of the authors of the guide. “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 for 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 for 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 for 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 road map showing the spectrum of potential approaches for this transition.

ISPE will now include the Appendix 2 from the ISPE Guide: Science and Risk-Based Approach for the Delivery of Facilities, Systems, and Equipment Guide with purchases of the Baseline Guide, Volume 5 document to assist companies 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. 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.

For more information on the ISPE Good Practice Guide: Applied Risk Management for 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.

About The Author

ISPE

The International Society for Pharmaceutical Engineering (ISPE) is a global nonprofit association of 22,000 pharmaceutical professionals in 90 countries who use knowledge to create high-quality, cost-effective good manufacturing practices (GMP) solutions. ISPE provides its members opportunities to develop technical knowledge, exchange practical experience within their community, enhance their professional skills, and collaborate with global regulatory agencies and industry leaders. Founded in 1980, ISPE offers online learning for a global audience. Its world headquarters are in Tampa, Florida, with offices in Brussels, Belgium, Shanghai, China, and Singapore.