5 June 2008

ICH Officials Announce Adoption of Q10 at ISPE’s Washington Conference

by Rochelle Runas, ISPE Technical Writer

The final draft of the much anticipated ICH Guideline Q10 (Pharmaceutical Quality Systems) has been adopted by the ICH Steering Committee, ICH officials announced 5 June at the ISPE 2008 Washington Conference: Engineering Regulatory Compliance, Washington, D.C., USA.

During the ISPE educational session, “Regulatory Perspectives on Hot Topics, Regulatory Trends, and Observations,” members of the ICH Q10 Expert Working Group, including Joe Famulare, Deputy Director, Center for Drug Evaluation and Research (CEDER) Office of Compliance, US FDA; Moheb Nasr, Office of New Drug Quality Assessment (ONDQA), CEDER, US FDA; and Robert Baum, Executive Director, Pfizer, Inc., delivered the news live via teleconference from the ICH Steering Committee Meeting in Portland, Oregon, USA.

“We have successfully reached Step 4,” Famulare told 70 ISPE education delegates. “There is a consensus, we’ve signed off on it, and it is ready for publication.”

Famulare, Nasr, and Baum gave the latest update from the meeting, including highlights of the new document. Q10 includes a revised section on transfer of ownership of products to include additional information addressing quality. The document also includes a robust section on outsourcing with the key message that ultimate responsibility falls on the manufacturer.

Q10 describes a model for an effective quality management system for the pharmaceutical industry that can be implemented throughout the different stages of a product lifecycle. Implementation should facilitate innovation and continual improvement and strengthen the link between pharmaceutical development and manufacturing activities.

Having reached Step 4, Q10 moves immediately to the final step (Step 5: Implementation) of the process, which is regulatory implementation. This step is carried out according to the same national/regional procedures that apply to other regional regulatory guidelines and requirements, in the EU, Japan, and the US.

ISPE’s Product Quality Lifecycle Implementation (PQLI) initiative is helping industry define areas where they can provide the technical framework for implementation of QbD in regulatory submissions, and turn the ICH Guidelines Q8, Q9, and Q10 into a cross-functional and practical reality.

More information on Q10 is expected to be posted soon on the ICH Web site, www.ich.org.

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