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

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Material type: Text

TextPublication details: Boca Raton Taylor & Francis 2005Description: 578pISBN:

9781574445169

DDC classification:

615.152 PRO

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Holdings
Item type	Current library	Item location	Collection	Call number	Status	Date due	Barcode	Item holds
Reference Book	NIMA Knowledge Centre	6th Floor Silence Zone	Reference	615.152 PRO (Browse shelf(Opens below))	Not For Loan		P0001867

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Previous	615.152 PHA Pharmaceutical Process Validation	615.152 PHA Pharmaceutical Process Scale-Up	615.152 POT cGMP: Current Good Manufacturing Practices for Pharmaceuticals	615.152 PRO Process Validation in Manufacturing of Biophamaceuticals: Guidelines, Current Practices and Industrial Case Studies	615.152 SHA How to Practice GMP's: A Guide to cGMP Compliance with PAT and HACCP	615.152 SHA Quality in the Manufacture of Medicines and other Healthcare Products	615.152 SHA SOP Guidelines	Next

Written by top authorities in process validation, this reference explores current trends in the field and strategies for selecting the most appropriate quality control scheme. It offers practical guidelines, recommendations, and an abundance of case studies that showcase various techniques and approaches in the validation of biopharmaceutical processes. These include guidance on determining the life spans of chromatography and filtration media, process characterization and techniques for scaling-down unit operations in biopharmaceutical manufacturing, examples of contamination events, and practical methods for testing raw materials and in-process samples during various manufacturing stages.

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