Webinar - Mirabilis: Controlling potential genotoxic impurities encountered during API synthesis
Dr Mike Burns, Scientist at Lhasa, presents on the workings of Mirabilis in relation to assessing risk in accordance with regulatory guidelines.
Controlling potentially mutagenic impurities (PMIs) is a critical part of the development of any pharmaceutical product. The ICH M7 guideline outlines a series of control options that are aligned with risk-based principles. The Mirabilis software has been developed as an industry-standardised in silico tool for the calculation of purge factors of impurities according to the Teasdale approach, led by a cross-industry consortium.
Herein, we present on the development of Mirabilis and describe a theoretical case study which will highlight the process involved when performing a risk assessment aligned to control option 4 for regulatory submission using Mirabilis.