Industry news

ICH Q-IQG completes its work

At the recent ICH meeting in Seville the ICH Quality Implementation Working Group (Q-IWG), which has been publishing documents to assist with the implementation of ICH Q8, 9 & 10, decided that they had now completed all of the tasks set out in the applicable concept paper so they will not meet again.

Since reaching Step 4 and publication within the ICH regions, experiences by all parties with the implementation of the ICH Q8(R2), Q9 and Q10 Guidelines have resulted in the need for some clarification.

The Questions and Answers developed by the Q-IWG are intended to facilitate the implementation of the Q8(R2), Q9 and Q10 Guidelines, by clarifying key issues.
The document with the first and second set of Q&As was finalized under Step 4 in April and June 2009, respectively. In October 2009, a third set of Q&As was developed and approved by the Steering Committee for integration in the Q&A document (Q8/Q9/Q10 Q&As (R3)). In November 2010, a fourth set of Q&As was developed and approved by the Steering Committee for integration in the Q&A document (Q8/Q9/Q10 Q&As (R4)).

The ICH Quality IWG also prepared ‘Points to Consider’ covering topics relevant to the implementation of Q8(R2), Q9 and Q10, which supplement the existing Questions & Answers and workshop training materials already produced by this group. The document with the first and second set of Points to Consider Document was finalized in June and November 2011, respectively.

All Q-IQG deliverables are available at the ICH webpage (see at ‘Q8/Q9/Q10 implementation’ beside the respective ICH Q-guidelines):

• Q&As
• Training / Workshop material
• ‘Points to Consider’, which answered questions which popped up during the training breakouts