4th Annual Impurities Summit: Genotoxic and Beyond

ICH M7 guideline: beyond synthesis and process-related impurities in pharmaceuticals; applications and perspectives

Presented by Dr Landolfi to the online event: 4th Annual Impurities Summit: Genotoxic and Beyond Summit held on September 15-16, 2020, and organized by Vonlanthen.

Topics of her presentation are:

  • Extractables & Leachables: M7 approaches in defining limits
  • Cross-contamination: how to deal with genotoxicity and other endpoints for data-poor substances such as process intermediates
  • Occupational safety: the use of computational tools as per ICH M7 applied in the occupational exposure banding for data-poor substance

The ICH M7 provides a practical framework that is applicable to the identification, categorization, qualification, and control of genotoxic impurities in pharmaceutical products.

However, the same principles can be used in other fields, and in her presentation, Dr. Landolfi talked about the use of M7 principles and methodologies in safety evaluation and in defining the safety limits of contaminants (E&L) released in drugs or medical devices through contact materials, she will mention principles that can be used to define the PDE of residuals during cleaning procedures in shared facilities and she will show methods to ensure a safe environment in the workplace (OEL/OEB) when data-poor substances are managed.

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