THIS MEETING WILL RUN AS AN ON-LINE EVENT
Extractables and Leachables (E&Ls) have for a long time being an important consideration for devices and container closures for liquid or semi-solid products. However, it has been evident that for decades the guidance for E&Ls wasn't aligned with the safety based impurity guidance on other specific impurities, e.g. ICH Q3C (residual solvents), ICH Q3D (residual metals) and ICH M7 (mutagenic impurities).
This meeting will seek to provide an overview of the ICH process, the current situation for ICH Q3E and opportunities to influence the desired outcomes. Regulators and Industry will then describe the current situation and highlight areas where they would like to see change.
The disconnects between E&L guidance and ICH Q3D (residual metals) and ICH M7 (mutagenic impurities).will be described and those areas needing clarification and harmonisation will be highlighted. An overview of the current analytical and toxicological requirements for E&L will be provided before finishing with an update from the ELSIE (Extractables & Leachables Safety Information Exchange) consortium, which seeks to apply PDEs to common E&Ls
Extractables and Leachables (E&Ls) have for a long time being an important consideration for devices and container closures for liquid or semi-solid products. However, it has been evident that for decades the guidance for E&Ls wasn't aligned with the safety based impurity guidance on other specific impurities, e.g. ICH Q3C (residual solvents), ICH Q3D (residual metals) and ICH M7 (mutagenic impurities).
This meeting will seek to provide an overview of the ICH process, the current situation for ICH Q3E and opportunities to influence the desired outcomes. Regulators and Industry will then describe the current situation and highlight areas where they would like to see change.
The disconnects between E&L guidance and ICH Q3D (residual metals) and ICH M7 (mutagenic impurities).will be described and those areas needing clarification and harmonisation will be highlighted. An overview of the current analytical and toxicological requirements for E&L will be provided before finishing with an update from the ELSIE (Extractables & Leachables Safety Information Exchange) consortium, which seeks to apply PDEs to common E&Ls
