Proposal on How To Conduct a Biopharmaceutical Process Failure Mode and Effect Analysis (FMEA) as a Risk Assessment Tool

Hartmut F. Zimmermann; Norbert Hentschel

doi:10.5731/pdajpst.2011.00784

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Proposal on How To Conduct a Biopharmaceutical Process Failure Mode and Effect Analysis (FMEA) as a Risk Assessment Tool

Hartmut F. Zimmermann and Norbert Hentschel

PDA Journal of Pharmaceutical Science and Technology September 2011, 65 (5) 506-512; DOI: https://doi.org/10.5731/pdajpst.2011.00784

Hartmut F. Zimmermann

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Norbert Hentschel

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vol. 65 no. 5 506-512

DOI

https://doi.org/10.5731/pdajpst.2011.00784

PubMed

22293839

Published By

Parenteral Drug Association (PDA)

Print ISSN

1079-7440

Online ISSN

1948-2124

History

Published online October 5, 2011.

Author Information

Hartmut F. Zimmermann1 and
Norbert Hentschel2

¹Associate Director Process Validation, Boehringer Ingelheim and
²Director Global Technical QA Biopharma, Boehringer Ingelheim

Corresponding Author: Dr. Hartmut F. Zimmermann, Boehringer Ingelheim Pharma GmbH & Co. KG, 88397 Biberach, Germany; E-mail: hartmut.zimmermann{at}boehringer-ingelheim.com

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Proposal on How To Conduct a Biopharmaceutical Process Failure Mode and Effect Analysis (FMEA) as a Risk Assessment Tool

Hartmut F. Zimmermann, Norbert Hentschel

PDA Journal of Pharmaceutical Science and Technology Sep 2011, 65 (5) 506-512; DOI: 10.5731/pdajpst.2011.00784

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Proposal on How To Conduct a Biopharmaceutical Process Failure Mode and Effect Analysis (FMEA) as a Risk Assessment Tool

Hartmut F. Zimmermann, Norbert Hentschel

PDA Journal of Pharmaceutical Science and Technology Sep 2011, 65 (5) 506-512; DOI: 10.5731/pdajpst.2011.00784

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