An Automated Classification Workflow to Assist Expert Assessment and Regulatory Submission for ICH M7

A classification workflow tool has been developed by Lhasa Limited to aid in the submission of impurities under the ICH M7 guideline. The workflow uses two in silico tools, Derek and Sarah Nexus, alongside experimental Ames and carcinogenicity data to predict an ICH M7 class. This workflow tool presents the classifications in a submission ready format, while still allowing the user to supplement the workflow with their own data. The workflow currently provides an ‘Inconclusive’ classification for chemicals that are not well defined by the guideline. This poster describes how impurities are classified using the workflow, in order to facilitate discussion regarding whether those compounds with a predicted class of ‘inconclusive’ are being treated appropriately.