Process Validation for Manufacturing of Biologics and Biotechnology Products: Berlin Hilton Hotel, Berlin, Germany, 6 - 7 September, 2001

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Fred Brown, Anthony S. Lubiniecki
Karger, 2003 - Medical - 129 pages
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Attempting to fill the gap Regulatory documents and inspections have put increasing emphasis on process validation for all types of products, including biological and biotechnological ones. Until now, no description of a process validation for complex biological processes exists, let alone any concrete suggestion how to attain it: this book, however, attempts to fill the gap. Taking the current state of scientific practice in process validation as a starting point, this volume portrays the expectations of the regulatory community and provides detailed examples of how various types of biological and biotechnological processes could be validated. Considering the sizeable difficulties in designing a single method of process validation suitable for all types of processes and products, the authors discuss the implications and present many possible routes to a successful validation process.

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Contents

Industry Perspectives
9
Session II
15
An Inspectors Viewpoint
27
Copyright

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