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


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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.Most of the consumer Reviews tell that the "Process Validation in Manufacturing of Biopharmaceuticals: Guidelines, Current Practices, and Industrial Case Studies: 29 (Biotechnology and Bioprocessing)" are high quality item. You can read each testimony from consumers to find out cons and pros from Process Validation in Manufacturing of Biopharmaceuticals: Guidelines, Current Practices, and Industrial Case Studies: 29 (Biotechnology and Bioprocessing) ...

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