The International Society of Pharmaceutical Engineers (ISPE) second edition of Baseline Guide series: Risk-based Manufacture of Pharmaceutical Products, A Guide to Managing Risks Associated with Cross Contamination, also known as Risk-MaPP, is utilized by manufacturers to assess risk and determine where control strategies are necessary. The overall goal of Risk-MaPP is to provide a scientific, risk-based approach to managing the risk of cross product contamination in multi-product facilities.
One of the key components of the Risk-MaPP approach is the determination of acceptable daily exposure limits or ADEs. Often, these are also called PDEs (permitted daily exposure) limits or HBELs (health-based exposure limits). ADEs are based on the toxicological properties and pharmacology of the specific active pharmaceutical ingredient. According to the Risk-MaPP document, the ADE of active pharmaceutical ingredient is the estimated dose that is unlikely to cause an adverse effect if an individual is exposed to the API by any route, at or below this dose every day for a lifetime. Determination of the ADE should be performed by a qualified toxicologist and must be science-based, and data driven.
Occupational exposure limits (OELs) are health-based values that are used for preventing adverse health effects for workers. OELs should not be confused with the ADE/PDE. The OEL determines what is safe for the majority of healthy workers, for an eight-hour work shift and a forty-hour work week, and entire working lifetime.
OEL Fastrac monographs contain the determination of the ADE as well.
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