QP Current Practices Challenges and Mysteries_Almac_March2012

ContinuedLicensed Drug Products– Does the CTA take into account anymodification in relation to the MA or equivalent?– Are NIMPs in the study truly NIMPs?– Is the Drug Product the same as that detailed inthe CTA?– Is the expiry date the same or less than theexpiry date of the licensed lot?– Be wary of counterfeit material?