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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 21

Using General Recipes for Standardized Multiple Plant Manufacturing Science
Presented at the WBF North American Conference, March 5–8, 2006, by
Velumani Pillaivelumani.pillai@pfizer.comPfizer, MSC 724, 100 Route 206 NorthPeapack, NJ 07977 USA
Rob Burrowsrob.burrows@pfizer.comPfizer, MSC 420, 100 Route 206 NorthPeapack, NJ 07977 USA
Dennis Brandldnbrandl@brlconsulting.comBR&L Consulting, 208 Townsend Ct.Cary, NC 27511 USA

Abstract

Innovation in pharmaceutical manufacturing with faster development, faster new product release, robust process understanding, and vastly improved quality by design is a key component of the FDA’s 21st Century manufacturing initiative. A pioneering approach that uses General Recipes (GR) as ...

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