Process Validation in Manufacturing of Biopharmaceuticals: Guidelines, Current Practices, and Industrial Case Studies (Biotechnology and Bioprocessing)

Publisher

CRC Press

Publication Date

2005

Language

English

ISBN 10

1574445162

ISBN 13

9781574445169

Binding

hardcover

Edition

2nd Edition

Condition

New

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About this title

Synopsis

Written by experienced authorities in process validation, Process Validation in Manufacturing of Biopharmaceuticals explores current trends in the field and strategies for the selection of the most appropriate quality control scheme. It offers practical guidelines, recommendations, and an abundance of industrial case studies that demonstrate various techniques and approaches in the validation of biopharmaceutical processes. Provides specific examples of failure modes and effect analysis (FMEA) that help you establish this method in your organization

Review

an extremely timely release that should quickly become a primary reference tool in the pharmaceutical industry.

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