Chapter 5. Fundamentals of Quality Assurance

  1. Dr.-Ing. Stefan Behme

Published Online: 18 JUN 2009

DOI: 10.1002/9783527627691.ch5

Book Title

Manufacturing of Pharmaceutical Proteins: From Technology to Economy

Manufacturing of Pharmaceutical Proteins: From Technology to Economy

Additional Information

How to Cite

Behme, S. (2009) Fundamentals of Quality Assurance, in Manufacturing of Pharmaceutical Proteins: From Technology to Economy, Wiley-VCH Verlag GmbH & Co. KGaA, Weinheim, Germany. doi: 10.1002/9783527627691.ch5

Author Information

  1. Gardeschützenweg 64, 12203 Berlin, Germany

Publication History

  1. Published Online: 18 JUN 2009
  2. Published Print: 14 JAN 2009

ISBN Information

Print ISBN: 9783527324446

Online ISBN: 9783527627691

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CHAPTER TOOLS

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Keywords:

  • quality assurance;
  • basic principles;
  • benefit;
  • quality management;
  • ISO 9000 169;
  • quality management systems;
  • components in pharmaceutical area;
  • development

Summary

This chapter contains sections titled:

  • Basic Principles

  • Benefit of Quality Assurance Activities

  • Quality Management According to ISO 9000

  • Structure of Quality Management Systems

  • Quality Management System Components in the Pharmaceutical Area

  • Quality Assurance in Development

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