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?
I am not an expert on this topic, but I share my thoughts in case they provide additional insight.
If the pharmacopeial method does not include that extra process impurity within its scope, is there any other pharmacopeical method that includes it that could be applied for that material? If so, I would think then a verification of that method would be sufficient.
If there are none that could be used for that material, then I think a method validation is required. Either way, the safest approach would be to validate it.
Hopefully somene with more knowledge on this subject can elaborate.
The method coming from the vendor includes it (and is already previously validated by the vendor) and I want to qualify another third party lab on that method now but unfortunately transfer from the vendor lab is not an option so need to decide whether to verify it at the new lab or validate it again