ICH Q9 Quality Risk Management published as Revision 1

Recommendation

2/3 May 2024

Process Validation - Live Online Training

As you could read in December 2020, the International Council for Harmonisation (ICH) announced to revise the ICH Q9 Quality Risk Management Guidelines. A concept document provided the direction for the changes. The revision was accompanied by a "business plan". The final version was planned for June 2022. A draft and an ICH presentation on this already provided a deeper insight into the planned changes in November 2021. It states:

"The QRM principles and framework of ICH Q9 have been instrumental in introducing QRM approaches to both industry and regulators. However, the benefits of QRM, as envisaged by ICH Q9, have not yet been fully realized." These are as follows:

• High levels of subjectivity in risk assessments and in QRM outputs
• Failing to adequately manage supply and product availability risks
• Lack of understanding as to what constitutes formality in QRM work
• Lack of clarity on risk-based decision-making

The now published revision provides guidance on each of these four areas.

In the revised guidance, the terminology has been changed from 'risk identification' to 'hazard identification' to better reflect the existing risk assessment text.

As of 18 January 2023, the revision has reached stage 4 and will now go into implementation. A detailed analysis will follow shortly.

For more detailed information please also see the revised ICH Harmonised Guidedline Quality Risk Management Q9 (R1) on the ICH website.