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THE WBF BOOK SERIES--ISA 88 and ISA 95 in the Life Science Industries by The WBF

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CHAPTER 24

Manufacturing Science Model Extensions to Address Quality by Design and Risk Assessments
Presented at the WBF Make2Profit Conference, May 24–26, 2010, by
Velumani Pillaivelumani.pillai@pfizer.comPfizer, MSC 722, 100 Route 206 NorthPeapack, NJ 07977 USA
Dennis Brandldnbrandl@brlconsulting.comBR&L Consulting, 208 Townsend Ct.Cary, NC 27511 USA

Abstract

Pharmaceutical manufacturing is globalizing as never seen before. Innovation in manufacturing with faster development, faster new product release, robust process understanding, and vastly improved Quality by Design (QbD) is critical for advanced manufacturing organizations. The goal of QbD is to design a quality product and manufacturing process to consistently deliver the ...

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