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 guidelines, 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 also developed and then made available on the ICH website. This briefing package was intended to clarify the Guideline.
At the end of 2020, the ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) announced that it would revise the ICH Q9 guideline. After several years of work, the final revision was released as “R1” at the beginning of 2023. Changes were mainly made in four areas
- Subjectivity in risk assessment and QRM results
- Management of product availability risks
- Understanding how much formality is required for risk management
- Clarity on risk-based decision making
In addition, training material on risk review and hazard identification as the first step in QRM has been produced. Detailed training material on all these areas was published in October 2023; it consists of nine files totaling over 300 slides and some case studies.