Process Robustness – A PQRI White Paper
نویسنده
چکیده
NOVEMBER/DECEMBER 2006 PHARMACEUTICAL ENGINEERING On-Line Exclusive 1 www.ispe.org/PE_Online_Exclusive ©C op yr ig ht IS PE 2 0 0 6 The Product Quality Research Institute (PQRI) is collaborative effort between the pharmaceutical industry, regulatory agencies, and academia. One of the purposes of PQRI is to promote discussion on current topics of interest in the pharmaceutical field. To that end, PQRI commissioned a working group to develop a White Paper that discusses the concept of process robustness and how it applies to development, scale up, and manufacture of pharmaceutical products. Process Robustness – A PQRI White Paper
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