Pharmaceutical manufacturers need to know whether their products contain nitrosamine impurities and, if so, whether they are below the thresholds established by various regulatory agencies.
Nitrosamines are highly toxic compounds, with some considered even more carcinogenic than currently established thresholds suggest and are, therefore, subject to strict regulations in both the EU and the US.
The introduction of nitrosamine impurities can occur at any stage of the supply chain, from raw material processing to the manufacturing process to appearing as leachables from packaging and storage.
The EMA and FDA are shifting their focus to packaging materials as a potential source of nitrosamine impurities. This shift in focus means that manufacturers need to know what is in their packaging materials, whether they can leach nitrosamines, and how to mitigate potential problems.
Our services, designed and run by our team of experts, can help you fill in the gaps in your supply chain information and assess your packaging and storage processes for the presence of nitrosamines.
Check out how we can help here.