At a recent event this question was raised, I thought it would be good idea to bring it to our community:
Shall we refer to the ICHM7 guidance to calculate the AI limit of nitrosamine derivative for the finished drug product? Additioanlly, if the results is less than 30% of the AI limit, is there anything needed from the finished drug product manfacturer? How about if the results is less than 10% of AI limit? is there any control needed in the finished drug product?