Comments on the new ICH Q9 Guideline Q9 (Quality Risk Management) published
Recommendation
27/28 May 2025
Supervision of the Pharmaceutical Quality System: Challenges and Opportunities
Register now for ECA's GMP Newsletter
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.
Related GMP News
07.05.2025FDA is extending its Quality Management Maturity Programme
30.04.2025FDA Warning Letter on missing Audit Trails and Raw Data Review
23.04.2025New WHO Guideline Package: TRS 1060 published
16.04.2025EMA: QPs must provide a written final Assessment and Approval of Third-Party Audit Reports
15.04.2025Strategic Report published by the Critical Medicines Alliance
09.04.2025EMA's Plans for the next three Years