Hi, I think, yes, we always do the validation of raw materials because the conditions that described in Pharmacopoeia might be not same with our Lab's conditions (equipment, reagents, column etc); If we have all equipment, solvent, column, reagents as exactly as described in the Pharmacopoeia, we need only to do verification, not full validation. For doing this we generally use primary reference standards such as USP ref std, or others. Best regards
If the API vendor performed validation and the documents shared with you, then no need to perform validation. Only one time analysis enough with their method.
In my opinion, you should always perform validation of the methodology used in any activity, particularly in scientific activities, if you want to be sure that the outcome of the of the methodology used is the correct one.
Hi....
Normally its based on the condition.. If your going to use the API in R&D purpose validation of the methodology not required, you can follow the validated API vendor (DMF) method for analysis. IF your going to use the API for any commercial purpose validation has to be done as per requirement.
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