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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<strong>QP</strong> Roles <strong>and</strong>Responsibilities• Qualified Person must:– Ensure product has been manufactured inaccordance with»GMP»Product Specification File»Clinical Trial Application– Certify in a register or equivalentdocument that product satisfies provisionsof Article 13, 2001/20/EC.