Carry over limits for Niitrsoamines

[Yosukemino]

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.

Best practice to decontaminate work area of Nitrosamines

We are going to start nitrosamine testing at our site and are in the process of putting together a safety SOP. I want to know about decontamination of nitrosamine sample preparation work area. What are the best cleaning solutions , procedures and practices? [image]

Cleaning Validations Criteria

Is there any specific guideline on how to perform cleaning method validations for Nitrosamine after product change over. Most of the Nitrosamine are volatile.

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.