The International Council for Harmonisation (ICH) has adopted a revised version of its Q9 guideline that aims to improve current quality risk management (QRM) programs by creating more objective risk assessments, which could potentially reduce quality defects as well as drug shortages.
The ICH Q9(R1) guideline was published on 20 January, and updates the original guideline, which is now 18 years old. It covers the principles of QRM, the general QRM process, risk management methodology, the integration of QRM into industry and regulatory operations. It also has two annexes addressing QRM methods and tools and another on potential applications for QRM.
The final guideline is little changed from the Step 2 draft published in December 2021. (RELATED: ICH releases revised Q9 guideline to improve risk assessments, Regulatory Focus 3 January 2022)
The adopted guideline introduces a new section on managing and minimizing subjectivity in section 5.4 on risk management methodology…
