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.