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; and George Millili, Johnson & Johnson - MentorIntroductionObjectiveThe ability of a manufacturing Process totolerate the expected variability of rawmaterials, operating conditions, pro-cess equipment, environmental condi-tions, and human factors is referred to as objective of this Paper is to unify under-standing of the current concepts of processrobustness and how they apply to pharmaceu-tical manufacturing.
A PQRI White Paper www.ispe.org/PE_Online_Exclusive NOVEMBER/DECEMBER 2006 PHARMACEUTICAL ENGINEERING On-Line Exclusive 1 ©Copyright ISPE 2006 The Product Quality Research
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