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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Documentation requiredFor Drug Substance, Drug Product, Placebo• Certificate of Analysis– To verify compliance with the specification inthe IMPD / sIMPD• Lot specific GMP Statement for the manufacture,testing & packaging / labelling– To verify manufacture in accordance withGMP