The International Council on Harmonisation has published a draft revision of its Q9 quality risk management guideline. The document is now available for public consultation and ICH anticipates that it will be finalized in September 2022, a delay from the previously announced June 2022 goal.
The draft, which was published on 18 November, focuses changes on five main areas: subjectivity in quality risk management; supply chain risk management; clarification of the formality concept; risk-based decision-making;...
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