Factory IQ/OQ, A New Approach for Streamlining Validation of Cell Culture Equipment

  • Elisabeth Fraune
  • Wilfried Kappel
Chapter
Part of the ESACT Proceedings book series (ESACT, volume 1)

Abstract

The validation of cell culture processes together with the qualification of the related process equipment is getting more and more important in the pharmaceutical industry, and even pilot plants need to be operated in cGMP regulated environments. The user and supplier of a bioplant which must be compliant with FDA regulations has to be familiar with the methods for the validation of processes and the qualification of process equipment. The efforts for validation can be an important part of the total project costs and can be estimated as 10% to 20% of the total project costs. Therefore, the more experienced the manufacturer of the bioprocess plant or the supplier of peripheral equipment which is in operation within the bioplant and in the environment the greater the chance for controlling the validation costs.

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References

  1. Pharmaceutical Engineering Guides for New and Renovated Facilities, Commissioning and Qualification,Vol.5 (2001), eds. ISPE Pharmaceutical and Engineering Guide.Google Scholar
  2. Gamp 3 Guide for Validation of Automated Systems in Pharmaceudcal Manufacture (1998).Google Scholar

Copyright information

© Springer Science+Business Media Dordrecht 2001

Authors and Affiliations

  • Elisabeth Fraune
    • 1
  • Wilfried Kappel
    • 1
  1. 1.B. Braun Biotech International GmbHMelsungenGermany

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