Abstract
General validation principles are explained. Documentation requirements and the practical organisation of a validation project are described. The specific considerations for qualifying biopharmaceutical equipment and processes are described.
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References
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© 1999 Springer Science+Business Media Dordrecht
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Slater, S. (1999). Biopharmaceutical Validation: an overview. In: Walsh, G., Murphy, B. (eds) Biopharmaceuticals, an Industrial Perspective. Springer, Dordrecht. https://doi.org/10.1007/978-94-017-0926-2_13
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DOI: https://doi.org/10.1007/978-94-017-0926-2_13
Publisher Name: Springer, Dordrecht
Print ISBN: 978-90-481-5237-7
Online ISBN: 978-94-017-0926-2
eBook Packages: Springer Book Archive