Process Validation in Manufacturing of Biopharmaceuticals: Guidelines, Current Practices, and Industrial Case Studies
Sofer, Gail
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
Provides specific examples of failure modes and effect analysis (FMEA) that help you establish this method in your organization
Rok:
2000
Wydanie:
2
Wydawnictwo:
CRC Press
Język:
english
Strony:
402
ISBN 10:
1574445162
ISBN 13:
9781574445169
Serie:
Biotechnology and Bioprocessing
Plik:
PDF, 4.26 MB
IPFS:
,
english, 2000
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