Risk-MaPP, ADEs, and PDEs: Their importance to multi-product pharmaceutical manufacturing facilities

Biopharma EHS

In this episode of the Biopharma EHS Podcast, Dean M. Calhoun, CIH, President and CEO of Affygility Solutions, interviews Ms. Stephanie Wilkins, President of PharmaConsult US, on the subject of Risk-MaPP, ADEs and PDEs: Their importance to multi-product pharmaceutical manufacturing facilities. Risk-MaPP stands for Risk-Based Manufacture of Pharmaceutical Products. It is one of the International Society of Pharmaceutical Engineers' (ISPE) Base-line Guides. One of the essential components of Risk-MaPP is the determination of acceptable daily exposure (ADE) values. Calculation of ADEs is similar to the calculation of PDEs presented by European Medicines Agency (EMA). If you need an occupational exposure limit (OEL) or ADE for a pharmaceutical compound, please check out our entire catalog of OEL Fastrac monographs. We have many OEL monographs that come with ADEs.