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>Mysteries</strong>• What happens when things go wrong?– Controls in place have not been ‘effective’?• Manufacturing sites – inspectionsindicate critical findings• Lot specific non conformities identifiedpost release• Recall– Panic- not an option