Meeting Report of the Technical Education Committee Symposium: Management of DNA reactive (mutagenic) impurities in drug development

Abstract

The Technical Education Committee Symposium, Management of DNA reactive (mutagenic) impurities in drug development, sponsored by the Parenteral Drug Association (PDA) Japan Chapter, was held online on November 5, 2020. The symposium focused on the control of mutagenic impurities per ICH M7, and the speakers presented calculation methods and operational challenges regarding the use of purge factor calculations during the application of Option 4. In this symposium, risk assessment of nitrosamine impurities, which have recently become a significant issue in pharmaceutical quality control, was also a key topic. This article summarizes the presentation of each speaker at the symposium.