In 2010, the International Society of Pharmaceutical Engineers (ISPE) released Volume 7 of their Baseline Guide series: Risk-based Manufacture of Pharmaceutical Products, A Guide to Managing Risks Associated with Cross Contamination, or simply Risk-MaPP. 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. 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. Many of our OEL Fastrac monographs contain the determination of the ADE. Search our entire catalog for your specific API, then read the description to see if it includes the ADE. For those OEL Fastrac monographs that don’t include the ADE, we can revise the monograph for a small additional fee.
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The experts at Affygility Solutions are available for assistance in Risk-MaPP, and ADE determination. Contact us today.
Contact us for further information on our Risk-MaPP and ADE determination services.