ENGLISH

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

By Gail , Sofer

Book information

Publisher
CRC Press
Year
2000
ISBN
978-1-4200-0165-5, 978-0-8247-0249-6, 1-57444-516-2, 9781574445169
DOI
10.1201/b13997
Language
english
Format
PDF
Filesize
4 MB (4471141 bytes)
Series
Biotechnology and Bioprocessing
Edition
2
Pages
402\602
Time added
2014-02-12 18:00:00

Description

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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