Nitrosamine risk assessment (for chemical and Herbal applications)

Any application should include a risk assessment for the presence of nitrosamines based on the principles outlined in the ICH Q9 & ICH M7 guidelines. The risk evaluation should address not only risks from the manufacturing process but also those from the introduction of materials used in the manufacturing process (e.g. starting materials, reagents, solvents – fresh and recovered, etc.).

In the event that a risk of presence of nitrosamines is identified as a result of the risk evaluation, confirmatory testing should be carried out using appropriately validated and sensitive methods.

Where nitrosamine impurities have been detected, CEP holders should define appropriate specifications and introduce controls and if requested following the assessment might have to introduce amendments of the manufacturing to lower the presence of nitrosamine.

More information on nitrosamines

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