Is anyone aware of a nitrosamine guideline or requirements within the relevant guidelines (US, CA, EU, any other) that would define what needs to be done in case of a probiotic drug substances/products?
Thank you in advance for your comments.
This is an interesting one, Probiotics… Did you received a regulatory query about it?
By the way @gregorjug may i know- any nitrosamine formation/presence in your probiotic product?
Probiotics based on their site of action in gut and environmental conditions around the gut, i believe nitrosamine should not be concern in one angle!
Not (yet), but we’re having an internal discussion about that topic, because we would like to be aware of anything related to probiotics and nitrosamines.
We haven’t tested the product, as we don’t feel it is necessary to do so (as you also mentioned in your response). I was just curious on the HAs thinking on the topic to avoid any challenges or to proactively prepare what would be needed.