ABSTRACT:
Pharmaceuticals have been credited with curing many diseases; however, there are unintentional exposures to toxins from drugs that have occurred at the manufacturing site, which can pose considerable risks to employees' health through unintentional contact. Thus, there is a need for us to protect workers from these dangers by limiting their level of exposure. This is done by defining the level of exposure that is acceptable or "occupational exposure limit" (OEL). OEL is the airborne concentration(s) over eight hours of work per day, for either a Working Lifetime). A definition of "acceptable daily exposure"(ADE) and "permitted daily exposure"(PDE) are established to define what is the maximum quantity of a pharmaceutical ingredient that may be present as a contaminant in another product, without it being harmful to the health of the end user. When adverse effects related to the exposure to an ingredient can be identified, the Point of Departure (Pod) that would be used in risk assessment is selected. Composite safety factors must be used in order to derive both ADE and PDE values. Each composite safety factor must include a variety of uncertainties identified at the time of establishment of the drug(s) being evaluated.