ICH Q9 Training Package for Revision 1 published

Since 2005, the ICH Q9 guideline has been the state of the art when it comes to quality risk management. It found its way into the EU GMP Guideline, initially as Annex 20, and was then incorporated into Part III, where it is still to be found today. In addition, an ICH Q9 briefing package was developed and made available on the ICH website. This briefing package was intended to make the guideline clearer. New training material is now also available for revision 1 of the ICH Q9 guideline.

At the end of 2020, the ICH (International Council on Harmonisation) announced that it would revise the ICH Q9 Guideline. The final revision was released as "R1" at the beginning of 2023.  Changes were mainly made in four areas:

• A high degree of subjectivity in the risk assessments and the results of the QRM
• Inadequate management of supply and product availability risks 
• Lack of understanding of what constitutes a formality in QRM work 
• Lack of clarity on risk-based decision making

The ICH also published slides on the background to the revision. In these, the uncertainties of the industry regarding the risk review were pointed out and a training material to be created was mentioned again. This training material is intended to provide assistance in these four areas in particular.

And it was precisely this training material that was published in October. It is very comprehensive and comprises a total of over 300 slides divided into the following chapters:

• Formality in Quality Risk Management with 30 slides 
• Hazard Identification Part I with 26 slides 
• Hazard Identification Part II with 29 slides (this deals with considerations relating to the relationships of failure modes in the pharmaceutical environment) 
• Product Availability Risks with 57 slides 
• Risk-based Decision Making with 47 slides 
• Risk Review with 34 slides 
• Subjectivity in Quality Risk Management Part I with 27 slides (this deals with the identification and management of subjectivity) 
• Subjectivity in Quality Risk Management Part II with 52 slides (this deals with the question of what subjectivity is in quality risk management - background and theory) 
• The Impact of Subjectivity on a Remediation Approach to Data Integrity Issues (Case Study) with 11 slides

You can see from the number of slides per key topic where the ICH would like to provide additional support. These are the topics of hazard identification with 2 sets of slides and, in particular, the issue of subjectivity in quality risk management with 3 sets of slides and a total of 90 slides, i.e. almost 1/3 of the total number of all slides.

You find the slides on ICH´s webpage