ICH: Training materials for the Q9(R1) Guideline
In October 2023, the International Council for Harmonisation (ICH) published training materials to complement the revised Q9(R1) guideline on quality risk management.
The training materials are intended to assist the pharmaceutical industry in implementing the Q9 Guideline, which was revised in January 2023 (we reported).
The revised guideline includes important supplementary information on the following four areas:
- the subjectivity of risk assessments and QRM results,
- the risks of product availability,
- the lack of understanding of the formality of QRM activities, and
- the lack of clarity in risk-based decision-making.
The training material clarifies ambiguities on hazard identification, product availability, risk assessment, and formality and subjectivity training in nine modules.
Examples and case studies are used to illustrate some of the concepts presented in the guideline. The material can be downloaded as PowerPoint presentations from the ICH website.
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