Quality By Design Model for Biologics Drug Product Development

A set of case studies on the different aspects of biologics drug product manufacturing, the book aims to help design manufacturing processes that meet the specific quality attributes of a product. Testing should be used to confirm the quality of the product, not to find out whether it met quality parameters or not. Addressing government implementation of QbD standards around the world, this timely reference emphasizes the application of QbD principles in the production of biologics and pharmaceuticals. Targeted at professionals, students, and regulators.

Über den Autor / die Autorin

Joseph Phillips, (Indianapolis, IN), PMP, IT Project+, is the Director of Education for Project Seminars, a PMI Registered Education Provider. He has managed and consulted on projects for industries including technical, pharmaceutical, manufacturing, and architectural among others. Phillips has served as a project management consultant for organizations creating project offices, maturity models, and best practice standardization.

Zusammenfassung

A set of case studies on the different aspects of biologics drug product manufacturing, the book aims to help design manufacturing processes that meet the specific quality attributes of a product. Testing should be used to confirm the quality of the product, not to find out whether it met quality parameters or not. Addressing government implementation of QbD standards around the world, this timely reference emphasizes the application of QbD principles in the production of biologics and pharmaceuticals. Targeted at professionals, students, and regulators.

Produktdetails

• Autoren: Joseph Phillips, Phillips Joseph, Satish K. Singh, Satish K. Phillips Singh, Satish K./ Phillips Singh, Singh Satish K.
• Verlag: Wiley, John and Sons Ltd
• Sprache: Englisch
• Produktform: Fester Einband
• Erschienen: 01.03.2013
• EAN: 9780470887219
• ISBN: 978-0-470-88721-9
• Seiten: 300
• Serien: Wiley Series on Biotechnology; Wiley Series in Biotechnology and Bioengineering; Wiley Series on Biotechnology; Wiley Series in Biotechnology and Bioengineering
• Themen: Naturwissenschaften, Medizin, Informatik, Technik > Technik > Chemische Technik; Chemie, Qualitätssicherung, Life Sciences, Biowissenschaften, biotechnology, chemistry, Chemical Engineering, chemische Verfahrenstechnik, Biotechnologie i. d. Biowissenschaften, Biotechnologie i. d. Chemie, Process Development, Verfahrensentwicklung, Arzneimittelentwicklung