The Eight Criteria Defining a Good Chemical Manufacturing Process

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...

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Bibliographic Details
Published in:Organic process research & development 2012-11, Vol.16 (11), p.1697-1706
Main Authors: Dach, Rolf, Song, Jinhua J, Roschangar, Frank, Samstag, Wendelin, Senanayake, Chris H
Format: Article
Language:English
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Summary: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 “if it can be measured, then it can also be managed”, with the aim to offer chemists a helpful toolbox to effectively compare competing API synthesis routes.
ISSN:1083-6160
1520-586X
DOI:10.1021/op300144g