The International Council on Harmonization (ICH) has issued training materials to complement its revised Q9(R1) guideline on quality risk management aimed at assisting the pharmaceutical industry in navigating the newly revised guideline.
The guideline was published in January 2023 and updates the original document, which had been in effect since 2005 (RELATED: ICH adopts guidelines on quality risk management, Regulatory Focus 25 January 2023).
The training materials use examples and case studies to explore in more detail some of the concepts introduced in the guideline. The revised guideline introduced new principles on minimizing subjectivity in risk assessments, clarified what is meant by the term “formality” in risk assessments, and spelled out what is meant by good risk-based decision making…
