The Eight Criteria Defining a Good Chemical Manufacturing Process

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• 作者：Rolf Dach ; Jinhua J. Song ; Frank Roschangar ; Wendelin Samstag ; Chris H. Senanayake
• 刊名：Organic Process Research & Development
• 出版年：2012
• 出版时间：November 16, 2012
• 年：2012
• 卷：16
• 期：11
• 页码：1697-1706
• 全文大小：553K
• 年卷期：v.16,no.11(November 16, 2012)
• ISSN：1520-586X

文摘

As pharmaceutical API projects advance from Development to Chemical Production, the primary objective of the Process Research and Development (R&D) chemists is a smooth transfer of a well-developed, safe, scalable, robust, and economical chemical process to their customers in Chemical Production. Since the definition of a Good Chemical Manufacturing Process differs widely amongst different departments and companies, we herein summarize eight useful process evaluation criteria, and then demonstrate our deployment according to the guiding principle 鈥渋f it can be measured, then it can also be managed鈥? with the aim to offer chemists a helpful toolbox to effectively compare competing API synthesis routes.