Operations Research, Systems Engineering and Industrial Engineering Commons^™

Process Hazard Review For Drug Development, Rudolph R. Schwarz

Theses

The development of drugs has become increasingly complex, requiring the use of a wide variety of pharmaceutical actives and isolated intermediates, a majority of which are not always completely characterized with respect to their hazard potential. This can present a source of potential exposure to those who handle these substances during initial drug development, manufacturing of the drug active and ultimately the finished pharamaceutical product. It is, therefore, essential that safety and health information be documented and communicated during the entire drug development process.

The need for application of process hazard review techniques to the development of new drug materials …