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Application of RSM Risk Assessment Tool in Mirabilis

Johnston LA;

Presented by Laura Johnston, Business Development Manager, during the Lhasa vICGM: Interpreting ICH Q11 - A Risk Assessment Tool for Assessing Starting Material Acceptability

To protect patients from potential unknown impurities introduced prior to the GMP process, guidance is provided under ICH Q11. However, whilst the guidance has been in place for several years, inconsistent application of the principles still leads to discussions between sponsors and regulators. Due to the evolving regulatory environment, a Genentech/Roche/Chugai global working group was formed, which led to the evolution of an easy-to-use risk assessment tool for early development, which highlights specific risks as well as overall risk for each potential starting material nomination.

Laura discussed the possible application of this risk assessment methodology within Mirabilis, which currently provides an industry-standardised approach for the calculation of purge factors of potentially genotoxic intermediates.



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