In this webinar, Lhasa Principal Application Scientists, Fernanda Waechter and Diego Zulkiewicz Gomes demonstrated how ICH M7 risk assessments can be performed for impurities in an API, including the following steps:
- Identification of potential degradation impurities using Zeneth
- Identification of process related impurities
- Classification of impurities through Derek Nexus and Sarah Nexus plus expert review
- Establishing safe limits
- Evaluating exposure through purge calculations using Mirabilis
- Establishing control strategies