Permitted Daily Exposure Calculated
The importance of Health-based Exposure Limits (HBEL) through scientific toxicological risk assessment has grown in the pharmaceutical industry since the implementation of the European Medicines Agency's (EMA) 'Guideline on setting 'Health-based exposure limits for risk identification in shared facilities production of various medical items (EMA/CHMP/CVMP/SWP/169430/2012)'. Calculations for PDE (Permitted Daily Exposure) and ADE (Acceptable Daily Exposure). The EMA guideline asks for the development of HBELs to be utilised in evaluating the risks of residual active substance contamination through pharmaceutical products. Derivation and establishment of PermittedDaily Exposure (PDE), also known as AcceptableDaily Exposure (ADE), has thus become an integral part of the cleaning validation programme for pharmaceutical manufacturing facilities or Contract Manufacturing Organizations (CMOs), in order to comply with va...