ABSTRACT

I. PREAMBLE The concept of chemical processing responsibility at large was introduced in chapter 2, section “New Trends and Their Probable Impact on Bulk Drug Process Development,” including a discussion of thermochemical hazards in processing and thermochemical process safety as one of the three components of responsible chemical processing, the others being environmental protection and industrial hygiene. Indeed, the reader is urged to review that material by way of preparation for the different treatment to follow herein, since repetition will be avoided except when necessary for providing a comprehensive context.