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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Study SpecificDocumentation• Remember <strong>QP</strong> Legal Duties– Each batch of product has beenmanufactured…..according to GMP,Product Specification File (PSF) <strong>and</strong>Clinical Trial Application (CTA)• <strong>QP</strong> must have knowledge of– CTA which should be consistent with PSF