The EMA update mentions the need for confirmatory testing to evaluate nitrosamine impurities whenever a secondary or tertiary amine functional group is present in any component of Biological API's.

Isocyclosporin A is a rearranged degradation product formed by acid exposure of cyclosporin A under aqueous and non-aqueous conditions. Isocyclosporin A contains secondary amine which could potentially form nitrosamine impurity.

Does your product have biological API ? and Are you looking to develop and validate a suitable analytical method ?