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> Declaration• May be confused with the lot specific <strong>QP</strong>Statement of Release• Signed by <strong>QP</strong>, confirming…manufacturingsites to be used outside of the EEA operateto equivalent EU GMP st<strong>and</strong>ards• Protocol <strong>and</strong> Product specific• Submitted as part of the CTA to the relevantCompetent Authority• <strong>QP</strong> is taking personal responsibility forcertifying the sites