APIC NA Risk Assessment Template

Now updated APIC nitrosamine risk assessment template is available. The questionnaire is almost the same as Q4 of EMA/409815/2020 rev12 and CMDh/439/2022. It’s very practical. And the vulnerability or non-vulnerability of amine, hydrazine, hydrazide or hydrazone function can be written in the amine space.



I worry about the oversimplification of all these checklists (yes/no). We in the community know that risk assessment goes WAY beyond a simple yes/no answer. While I agree they are great tools for discovery and a preliminary assessment, they cannot become the sole risk assessment document.


Thank you for your good comments, @Naiffer_Host. I agree with you. I think justification is the most important in this kind of document. We used a similar questionnaire as a cover page and added other documents with the synthesis scheme and the information on used reagents to report details.

I think the most advantageous point of the questionnaire is that reviewers can understand the outline of the assessment at a glance. And if reviewers want to know details, they can read the additional reports. The questionnaire itself is not a perfect one for a risk assessment report.


This is a great help for those looking for a starting point. Thanks for sharing