QP Current Practices Challenges and Mysteries_Almac_March2012
QP Current Practices Challenges and Mysteries_Almac_March2012
QP Current Practices Challenges and Mysteries_Almac_March2012
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Lot Specific Information• Remember <strong>QP</strong> Legal Duties….– Each batch of product has beenmanufactured <strong>and</strong> assembled according toGMP, PSF <strong>and</strong> Clinical Trial Application• <strong>QP</strong> must therefore have knowledge of thespecific lot of– Drug Substance– Drug Product– Placebo