Bureaucracy, chemical process development

In chemical process development programs, discontinuities in introducing new processes, due to regulatory constraints, frequently cause the selection of suboptimal processes for development. Once established in manufacturing, even suboptimal processes can be difficult to replace (see earlier essay on Bureaucracy Reduction). Other agendas have also to be considered, as evidenced in our efforts to develop a new process for albuterol manufacture (see Chapter 5). In another case, lack of time, and perhaps also a lack of faith in the future market potential of Temozolomide, were major factors retarding the development of new processes for the manufacture of this API (see Case Study 2). 

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