Transcription of Process Robustness – A PQRI White Paper
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Process Robustness – A PQRI White Paper
A pqri White PaperNOVEMBER/DECEMBER 2006 PHARMACEUTICAL ENGINEERING On-Line Copyright ispe 2006 The ProductQuality ResearchInstitute ( pqri )is collaborativeeffort betweenthepharmaceuticalindustry,regulat oryagencies, andacademia. Oneof the purposesof pqri is topromotediscussion oncurrent topics ofinterest in thepharmaceuticalfield. To thatend, pqri commissioned aworking group todevelop a WhitePaper thatdiscusses theconcept ofprocessrobustness andhow it applies todevelopment,scale up, andmanufacture Robustness A pqri WhitePaperby pqri Workgroup MembersMichael Glodek, Merck Stephen Liebowitz, Bristol-Myers Squibb; Randal McCarthy,Schering Plough; Grace McNally, FDA; Cynthia Oksanen, Pfizer; Thomas Schultz, Johnson Mani Sundararajan, AstraZeneca; Rod Vorkapich, Bayer Healthcare; KimberlyVukovinsky; Pfizer, Chris Watts, FDA.
A PQRI White Paper www.ispe.org/PE_Online_Exclusive NOVEMBER/DECEMBER 2006 PHARMACEUTICAL ENGINEERING On-Line Exclusive 3 ©Copyright ISPE …
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