Friday, March 18, 2011

Process Validation in Manufacturing of Biopharmaceuticals: Guidelines, Current Practices, and Industrial Case Studies: 29 (Biotechnology and Bioprocessing)

Process Validation in Manufacturing of Biopharmaceuticals: Guidelines, Current Practices, and Industrial Case Studies: 29 (Biotechnology and Bioprocessing)

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Product 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

Process Validation in Manufacturing of Biopharmaceuticals: Guidelines, Current Practices, and Industrial Case Studies: 29 (Biotechnology and Bioprocessing) Review

Overall this book is a very useful tool for gettig accustomed to regulatory CMC requirements. Some chapters are more comprehensive and detail oriented than others. The case studies included are definitely useful. For someone who is just getting their feet wet in this domain, the book is definitely a life line. For a more advanced person, it might not offer too much.

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