Nitrosamine Testing: The Regulatory Aspects
In July 2018, N-Nitrosodimethylamine (NDMA) was identified in an active pharmaceutical ingredient (API). This was the first time a nitrosamine impurity had been detected in a pharmaceutical product. It led to regulatory warnings and product recalls, and wider recognition that pharmaceutical manufacturers should adopt a proactive approach to risk assessment and mitigation in relation to genotoxic contaminants.
In this paper, we review the nitrosamine impurities limits accepted by the regulatory agencies, look at risk assessement and the regulatory perspective and then explain a three step approach to evaluate risk, confirmatory testing and the corrective actions to take to comply with FDA, EMA and Health Canada.