Chromatography Forum

When verifying a pharmacopeial method for material coming from a supplier, for example a Related substances pharmacopeial method and the material being supplied has an extra process impurity unique to that supplier, would that require a full validation to be done because of the extra impurity or would a 'verification' level of qualification still be sufficient?

You can amend you existing validation with justification. I dont think full validation is needed

perform the verification first with a little bit extra for the specific in-process impurity.