Case Study on Nitrosamine Impurities in Human Drugs Regulatory Perspective

Abstract

Nitrosamine impurities have recently been the focus of Global Regulatory Agencies. After the first identification of N-nitrosodimethylamine, this impurity has been considered a “cohort of concern” because of its potential carcinogenic risk to humans in the long term. Investigations have led to a conclusion that although Nitrosamine impurities are present in trace amounts, we need to implement the standard control protocols in pharmaceutical industries. This project is a review about the past, present and future of Nitrosamine impurity through regulatory perspective. It embraces the risks, causes and precautions which the regulatory agencies advised or are still advising in such a short timeline for protection of public health. The review also highlights the current and future impact of the Nitrosamine crisis in the regulatory field.