Hello everyone,
I hope you’re all doing well. I have a query regarding cleaning validation requirements specifically related to nitrosamines. I would greatly appreciate your insights and opinions on this matter.
Do you believe it is necessary to include nitrosamines in cleaning validation requirements? What is your opinion on this topic?
I am particularly interested in hearing about your experiences, knowledge, and any regulatory guidelines or industry standards that you may be aware of. It would be helpful to know how different organizations handle this issue and what best practices are currently being followed.
Thank you in advance for your valuable input. I look forward to reading your responses and engaging in a fruitful discussion.
Best regards,
Anuj Kaushal.
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I believe this topic is worth discussing on the forum for a productive outcome.
There are several posts where cleaning and impact have been discussed. I suggest searching and exploring…
HI Team,
Thanks for putting this subject for discussion. As per few of the literature available, cleaning of the process equipment are also considered as a risk for the carry over of Nitrosamines. However, if we are dealing with the small molecule nitrosamines like NDMA/NDEA etc, the levels of these impurities will proportionately go down with respect to the active substance during cleaning process. Based on this proportionate scale down, the theoretical value of this impurity will be too low to be detected by any of the technique. So we can adopt this approach to justify the levels of carryover.
However, in case of NDSRI, worst case we can consider the level of this impurity same as the maximum residue acceptable for drug substance as per calculation.
Going forward, we may also apply the approach that the maximum level of impurity by above approach will be again going to be diluted in the whole batch of the next product & again the value can go down.