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Zimmermann, Hartmut F; Hentschel, Norbert (2011). Proposal on How To Conduct a Biopharmaceutical Process Failure Mode and Effect Analysis (FMEA) as a Risk Assessment Tool. PDA journal of pharmaceutical science and technology, 65(5), pp. 506-12. Bethesda, Md.: PDA 10.5731/pdajpst.2011.00784