ICH Information Material on the ICH Q9 revision Quality Risk Management

Since 2005, the ICH Q9 Guideline on Quality Risk Management has represented the state of the art. A revision was announced at the end of 2020.  In January, this revision has reached stage 4 and is now moving into implementation.

You will find a detailed analysis in this GMP news article. ICH now provided slides that give a deeper insight into the revision. Spanning 29 pages, the set of slides describes the background of the revised guideline, its objectives through to its implementation. The table of contents includes:

• Disclaimer
• Background
• Key Principles 
• Objectives of the Guideline (subjectivity in quality risk management, risks related to product availability, formalities in quality risk management, risk-based decision making, the objective itself)
• Table of Contents
• Overview of Guideline Content (including cross-references to ICH Q10)
• Results of the Public Consultation
• Considerations
• Guideline for Implementation 
• Conclusion
• Contact

Key principles identified are:

• Subjectivity in risk assessments and QRM results
• Inadequate management of supply and product availability risks
• Lack of understanding about QRM formalities
• Lack of clarity about risk-based decision making

There is one more interesting note in the Key Principles chapter. It is noted that the topic of "Risk-Review" needs additional clarification. However, no changes were made to this topic in the guideline itself. Clarification will be provided via the training material that is currently being prepared.

Slides 14-20 clarify the six requirements that were targeted for change.

Slides 21-22 explain the references to the ICH Q10 document. Explicitly mentioned are references to knowledge management in ICH Q10 and to points 1.6.1 and 2.7 of the Q10 guideline.

The information on the results of the public consultation is also interesting. Approximately 775 comments were submitted and evaluated at Stage 3 of the ICH process. Some comments were also incorporated into the revision, such as the introduction of a separate subchapter on subjectivity to emphasize the importance of this topic. The importance of root cause analysis was also emphasized more in the revision as a result of the comments. References to ICH Q11 and Q12, as well as updating ISO standards, are also results of the comments.

Also of interest is the comment in the Guideline for Implementation chapter that the ICH Q9 guideline in the revision is a fundamental guideline and supports the implementation of the other ICH guidelines Q7, Q8, Q10, Q11, Q12, Q13, as well as other quality guidelines. The target audience is addressed as industry and authorities. Explicitly addressed is the change in terminology from risk identification to hazard identification. It is not expected that already existing risk assessments will have to be adapted accordingly. Future risk assessments should naturally consider the change. It is important to note again that the ICH Q9 revision should be read in conjunction with the training material yet to be produced.

The conclusion again refers to the four key principles mentioned above and the change in terminology from risk identification to hazard identification. It also mentions the training material to be prepared, which is considered as support, especially also with regard to the "Risk-Rewiew". Finally, the integration of industry comments is discussed.

Conclusion: The slides give a great overview of the background and objectives of the ICH Q9 revision. It will be exciting to see how the training material mentioned several times will "support" the revised ICH Q9 guidelines.

The entire slide set is available on the ICH website.

At the ECA GMP & GDP Forum on June 20-22, 2023 in Barcelona, a member of the Expert Working Group for the revision of ICH Q9 will speak about the changes.