ICH Q9(R1) Guideline on Quality Risk Management reached Step 4 on 18Jan23
Pierre Mermet-Bouvier
eCOAs I Regulatory Affairs I Transparency I PMO I Regulatory Intelligence I Clinical Operations I Global and Transversal Teams I Process Improvement I Operational Excellence I Strategic Planning
Friday 20Jan23, ICH released the information in its Newsroom that the ICH Q9(R1) Guideline on Quality Risk Management has reached Step 4 of the ICH Process on 18Jan23.
Initial Q9 Guideline (23 pages) was released in Nov05. The revised Guideline (R1) is 29 pages.
Main changes are:
1) "Risk management methodology" chapter 5 was developed to include 3 new subchapters:
2) A new Annex II: Potential Applications for Quality Risk Management
"II.9 Quality Risk Management as Part of Supply Chain Control" was added.
3) I can also mention the addition of 2 new Definitions (Chapter 7)