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…• Critical or major deviations / Out of Specificationinvestigations for manufacture / storage / testing– Drug Product– Placebo• Why?– To identify any possible impact on• Product quality• Patient Safety