Carry over limits for Niitrsoamines

Dear Nitrosamines exchange Team,

Could anyone throw light on resources/guidance that talked or discussed about cleaning procedures to be in place to avoid nitrosamine contamination with multiple products manufactured in facility.
I see there is guidance and development in aspects of control of nitrosamines limits in marketing/manufactured products for patient safety.
How to find levels of nitrosamines that can be allowed as contaminant from one drug product to another drug product, considering a case where nitrosamines being challenging to control at stringent levels and developing analytical methodology- How to establish a clear-cut maximum allowable carry over limit?

Hi, @Pradpharma,

I’m unsure about the guidance describing cleaning validation specific for nitrosamine contamination. ICH Q3E targets nitrosamines, but it’s now under discussion. And following two threads may help you.

The concept of cleaning validation is still valid for nitrosamines, I think. And we should evaluate the risk of nitrosamine carry-over on a case-by-case basis.


Thanks @Yosukemino for your quick direction to suitable sources.
Information from @ASrinivasan is worthy to note!