The safety, quality and clinical results of drug substances and drug products may be disrupted by the formation of nitrosamines along with other mutagenic impurities. The comprehensive development and production of innovative medicines now inevitably involves estimating impurity profiles as well as managing and monitoring them. To meet the demands of ever-increasing regulatory standards and avoid expensive recalls, proactive detection of genotoxic contaminants should be adopted at every stage of pharmaceutical development.
We plan an online meeting with subject-matter experts to evaluate multiple perspectives on how to handle the concerns of mutagenic impurities. We will cover regulatory-compliant drug impurity profiling practices; helpful hints for adhering to recent ICH M7 and Q3D updates; nitrosamine impurity identification and quantification; risk evaluation of genotoxic impurities; analytical challenges and genotoxicity prediction; establishment of acceptance criteria; and the most recent developments in the analysis of elemental impurities.
Save a seat at our webinar to find out about most effective methods for genotoxic and other mutagenic impurity management.