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Process Validation in Manufacturing of Biopharmaceuticals.

Author: Anurag S Rathore
Publisher: Hoboken : CRC Press, 2012.
Series: Biotechnology and Bioprocessing.
Edition/Format:   eBook : Document : English : 3rd edView all editions and formats
Summary:
Process Validation in Manufacturing of Biopharmaceuticals, Third Edition delves into the key aspects and current practices of process validation. It includes discussion on the final version of the FDA 2011 Guidance for Industry on Process Validation Principles and Practices, commonly referred to as the Process Validation Guidance or PVG, issued in final form on January 24, 2011. The book also provides guidelines and  Read more...
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Genre/Form: Electronic books
Additional Physical Format: Print version:
Rathore, Anurag S.
Process Validation in Manufacturing of Biopharmaceuticals.
Hoboken : CRC Press, ©2012
Material Type: Document, Internet resource
Document Type: Internet Resource, Computer File
All Authors / Contributors: Anurag S Rathore
ISBN: 9781439850947 1439850941 1439850933 9781439850930
OCLC Number: 793193185
Description: 1 online resource (523 pages).
Contents: Front Cover; Contents; Preface; Editors; Contributors; Chapter 1: Guidelines to Process Validation; Chapter 4: Process Characterization; Chapter 6: Adventitious Agents: Concerns and Testing for Biopharmaceuticals; Chapter 8: Validation of a Filtration Step; Chapter 9: Analytical Test Methods for Well-Characterized Biological and Biotechnological Products; Chapter 10: Facility Design Issues: A Regulatory Perspective; Chapter 11: Validation of Computerized Systems; Chapter 12: Process Validation with a CMO; Chapter 13: Risk Management and Validation. Chapter 14: Process Validation in Membrane ChromatographyChapter 15: Leveraging Multivariate Analysis Tools to Qualify Scaled-Down Models; Chapter 16: Process Validation of a Multivalent Bacterial Vaccine: A Novel Matrix Approach; Chapter 18: Viral Clearance Validation: A Case Study; Back Cover.
Series Title: Biotechnology and Bioprocessing.

Abstract:

Process Validation in Manufacturing of Biopharmaceuticals, Third Edition delves into the key aspects and current practices of process validation. It includes discussion on the final version of the FDA 2011 Guidance for Industry on Process Validation Principles and Practices, commonly referred to as the Process Validation Guidance or PVG, issued in final form on January 24, 2011. The book also provides guidelines and current practices, as well as industrial case studies illustrating the different approaches that can be taken for successful validation of biopharmaceutical processes. Case studies.

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