Process Validation in Manufacturing of Biopharmaceuticals: Guidelines, Current Practices, and Industrial Case Studies

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Gail Sofer
Taylor & Francis, May 6, 2005 - Medical - 600 pages
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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

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