Comments on the new ICH Q9 Guideline Q9 (Quality Risk Management) published

Recommendation

13/14 December 2023
Berlin, Germany

Root Cause Analysis
A CAPA Workshop on Successful Failure Investigation

Since 2005, ICH Guideline Q9 has been the state of the art when it comes to quality risk management (QRM) in the GMP environment. Now it was time for a revision. For this purpose, the draft of a revised document was published in December last year by the ICH but also by the European Medicines Agency (EMA). With 33 pages, the draft was more extensive than the previous version with 19 pages. However, this was also due to the fact that each line was numbered for better commenting and line spacing was increased as a result.

But there were also some important new passages on topics such as:

• Subjectivity
• Risk-based decision-making
• Supply chain complexity

The then published draft of this first revision was open for comment. The ECA Foundation together with its European QP Association had also set up an expert working group to comment on the draft. This expert working group was chaired by Yves Samson. The comment period ended on 15 March 2022, and the EMA has now published the comments received.

The comments will now be forwarded to the ICH Q9(R1) EWG for consideration as part of Step 3 of the ICH process.