Date of Award

Spring 1987

Document Type

Thesis

Degree Name

Master of Science in Management Engineering - (M.S.)

Department

Industrial and Management Engineering

First Advisor

John Mihalasky

Abstract

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 is becoming increasingly more evident. Developing trends in health and safety legislation, along with changes in the technical aspects of accident control, now make utilization of process hazard review programs in the pharmaceutical industry a necessary element in preventing employee injury and health hazards during drug development. Often little time is devoted to formal safety reviews during the research and development (scale-up) stages where valuable safety data is likely to be generated. Therefore, it is desirable to implement and use it to control potential hazards.

The primary aim of this paper is to provide a practical resource for safety personnel which stresses the importance of conducting process reviews at all stages of drug development. It will provide a process review format for recording new safety and health data as it is generated to assist in the prevention of accident/injury and capital loss. The paper is also intended to promote the use of safety reviews in drug development, and to help the safety professional become more involved in the transfer of safety and health information during that process.

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