18. Quality and Risk Management in Ensuring the Virus Safety of Biopharmaceuticals

  1. Dr. Ganapathy Subramanian
  1. Andy Bailey

Published Online: 15 OCT 2012

DOI: 10.1002/9783527653096.ch18

Biopharmaceutical Production Technology, Volume 1 & Volume 2

Biopharmaceutical Production Technology, Volume 1 & Volume 2

How to Cite

Bailey, A. (2012) Quality and Risk Management in Ensuring the Virus Safety of Biopharmaceuticals, in Biopharmaceutical Production Technology, Volume 1 & Volume 2 (ed G. Subramanian), Wiley-VCH Verlag GmbH & Co. KGaA, Weinheim, Germany. doi: 10.1002/9783527653096.ch18

Editor Information

  1. 44 Oaken Grove, Maidenhead, Berkshire SL6 6HH, United Kingdom

Author Information

  1. Virusure GmbH, Wissenschafts- und Technologiepark, Donau-City-Strasse 1, 1220 Wien, Austria

Publication History

  1. Published Online: 15 OCT 2012
  2. Published Print: 18 JUL 2012

ISBN Information

Print ISBN: 9783527330294

Online ISBN: 9783527653096

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Keywords:

  • biopharmaceutical;
  • safety;
  • virus;
  • contamination;
  • quality control;
  • risk minimization;
  • guideline

Summary

This chapter contains sections titled:

  • Introduction

  • QRM and Virus Safety

  • Pillars of Safety

  • Committee for Proprietary Medicinal Products Guidelines for Investigational Medicinal Products–Risk Management in Practice

  • Developing a Robust Risk Minimization Strategy–What Is the Correct Paradigm?

  • References