ICH Q2(R2) Validation of analytical procedures - Scientific guideline | European Medicines Agency (EMA)
This guideline presents a discussion of elements for consideration during the validation of analytical procedures included as part of registration applications submitted within the ICH member regulatory authorities. It provides guidance and recommendations on how to derive and evaluate the various validation tests for each analytical procedureand serves as a collection of terms, and their definitions. This guideline applies to new or revised analytical procedures used for release and stabilit...| European Medicines Agency (EMA)
