The Role of the Occupational Toxicologist in Pharmaceutical Contract Manufacturing

Pharmaceutical contract manufacturingcompound is typical classified or categorized into
organizations (CMOs) are retained by a widethe CMO's control banding scheme. The purpose
range of life science companies to perform aof placement of compounds into a control band is
even wider range of activities. These companiesto define the potential range of exposures, and
can range from small start-up biotechnologythe engineering, administrative and personal
companies with little experience in the drugprotective equipment necessary to maintain
development process to large internationaloccupational exposures to within a certain range
pharmaceutical companies who are in need ofof airborne concentrations of the active
additional manufacturing capacity. Activitiespharmaceutical ingredient.
performed by these organizations can range fromIn addition to classifying prospective compounds,
synthesis of active pharmaceutical ingredients tothe occupational toxicologist may have additional
packaging and labeling of the final product.responsibilities such as authoring material safety
Frequently, pharmaceutical contract manufacturingdata sheets for drug compounds, investigating
organizations will retain the services of aallegations of adverse health effects, and working
professional occupational toxicologist to evaluatewith industrial hygiene professionals in defining or
prospective compounds for potential occupationalevaluating the controls necessary to maintain
hazards. These hazards can include both acuteexposure to a safe level.
effects such as dermatitis and/or central nervousWith the recent expansion of chemical safety
system effects to chronic effects such as cancerregulations, both in Europe and in the United
or reproductive disorders. Once the potentialStates, the role of the occupational toxicologist in
occupational hazards have been evaluated by thethe pharmaceutical contract manufacturing
occupational toxicologist, the prospectiveorganization will become increasingly important.