The ICH published a 29-page presentation on the revision of ICH Q9 on 14th of March 2023 (ICH Q9(R1) Quality Risk Management). The guideline on quality risk management was published in January 2023 and will come into force in July 2023. Revised guideline covers the principles of quality risk management (QRM), the general QRM process, the QRM methodology and the integration of QRM into industry and regulatory processes. It also includes two annexes on QRM methods and tools and another on possible applications of QRM.
The presentation answers the questions about the “how” and “why” of the revision of ICH Q9 and describes the background of the revised guideline, its objectives through to its implementation. The table of contents includes:
- 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
- Guideline for Implementation
Key principles identified are:
- the importance of subjectivity and formality in QRM
- risks to product availability in the absence of QRM
- insufficient strategic tracking and consistency in risk-based decision making
- summaries of the guideline content and the results of the public consultation
- cross-references to ICH Q10
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. Overall, a comprehensive overview of the objectives and background of the ICH Q9 revision has been prepared by the Expert Group (EWG) based on the concept paper, the business plan, and the work plan laid down in 2020. Further training material has been announced.