ICH Position Papers Will Address Pressing Issues in Q8-10 Implementation; EU Experience Helps Shed Light

The ICH Quality Implementation Working Group (IWG) is progressing in its effort to develop a series of six position papers covering issues identified by the industry and health agency participants at the 2010 ICH Q8-10 training sessions as needing further clarification. The IWG is planning to complete the six papers by the end of 2011.

The first three of the six are now being prepared with the goal of finishing them at the ICH meeting in Cincinnati, Ohio in June. These three will cover: ● criticality ● the control strategy, and ● what to include in dossiers.

The second three – to be developed in the latter part of the year – will cover ● design space ● the role and maintenance of models in QbD, and ● process validation/continuous process verification.

The papers represent a final project for the IWG, which was formed in 2008 to foster a harmonized interpretation of the principles in the Q8-10 guidelines and support the implementation of the new quality paradigm in the ICH regions and globally.

[More on the ICH position papers and the issues that they will be addressing from the ICH training workshops, along with related insights from the EU experience with QbD applications to date, is provided for subscribers hereThe full story can be purchased for $195 by contacting Jonathan Trethowan (Jonathan@ipq.org).  For subscription and license information, click here.]