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Since the denition of a Good Chemical ManufacturingProcess diers widely amongst dierent departments and companies, we herein summarize eight useful process evaluation criteria,and then demonstrate our deployment according to the guiding principle if it can be measured, then it can also be managed,with the aim to oer chemists a helpful toolbox to eectively compare competing API synthesis routes.ĭespite commonly considered recession-proof, large pharma-ceutical companies have been adversely aected by the recentglobal slowdown. Box 368,Ridgeeld, Connecticut 06877, United StatesĪBSTRACT: As pharmaceutical API projects advance from Development to Chemical Production, the primary objective of theProcess Research and Development (R&D) chemists is a smooth transfer of a well-developed, safe, scalable, robust, andeconomical chemical process to their customers in Chemical Production. KG, Binger Strae 173, 55216Ingelheim am Rhein, GermanyDepartment of Chemical Development US, Boehringer Ingelheim Pharmaceuticals, Inc., 900 Ridgebury Road/P.O. Senanayakeĭepartment of Process Development Chemicals, Boehringer Ingelheim Pharma GmbH & Co. Song, Frank Roschangar,*, Wendelin Samstag, and Chris H. The Eight Criteria Dening a Good Chemical Manufacturing ProcessRolf Dach,*, Jinhua J.

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