A Global Approach to Nitrosamine Impurity Testing for Drug Products

Manufacturers and regulatory authorities around the world are now aware of the potential threat posed by nitrosamine impurities in API/DP. By taking a global, collaborative approach to the problem, they have created a regulatory landscape which allows stakeholders to develop proactive risk assessment
strategies that cover a wide range of markets. Romain Simon at SGS addresses the potential risk for contamination of biologic drugs with nitrosamines.