9 November 2017
Webinar: 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.
During this webinar, Larry Wigman, Principal Scientific Manager at Genentech, discussed;
- The selection of Regulatory Starting Materials based on the EMA Reflection Paper and ICH Q11 Q&A documentation
- The disclosure of more Synthetic Steps and more highly reactive, potentially genotoxic intermediates
- Leveraging M7 Control Options and Purging Rationale
Laura Johnston, Business Development Manager at Lhasa Limited, 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.
Please see the recordings and slides using the links below.
Headline Event (shown first above featured)
- Application of RSM Risk Assessment Tool in Mirabilis
- Interpreting ICH Q11: A Risk Assessment Tool for Assessing Starting Material Acceptability