Packaging materials can be a potential source of nitrosamines, either through the migration of these compounds from the packaging into the drug product or through chemical reactions that occur within the packaging environment.

Balancing risk assessment and confirmatory testing for nitrosamines is a complex task that requires a deep understanding of both the product and the processes involved in its manufacture. By creating a thorough risk assessment, gathering sufficient scientific data, ensuring analytical

By conducting thorough inventory assessments, reviewing manufacturing processes, and understanding the regulatory landscape, companies can proactively manage nitrosamine risks. Regular testing, compliance with global guidelines, and a focus on cross-departmental communication are essential steps in mitigating the risks associated with