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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Continued• Additional information required• Sponsor supplied Risk Assessment• <strong>Almac</strong> Risk Assessment– Impact Assessment• Discussions with Regulator as required• Outcome determined; Product to– Remain at site– Be recalled– Be released