New ICH Guideline Q14

Have anyone of you read the new upcoming ICH - Guideline Q14 ?
It will be effective from 14/06/2024.
ICH Q14 Guideline on analytical procedure development_Step 5 (
What seems new to me is that, sample suitability testing is mentioned.

Interference from the matrix often causes signal suppression on LC-MS, so it makes sense to check for this. In the environmental field recovery has to be performed on every sample set.
I don´t know how to interpret this document and whether sample suitability testing will be required in the future.


1 Like