Permitted Daily Exposure (PDE)/ Acceptable Daily Exposure (ADE) REPORTS for APIs

Health based exposure limits (HBEL) have to be determined for all APIs of human and veterinary medicinal products produced in multi-purpose facilities, according to EMA guidelines (“Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities” (EMA /CHMP /CVMP/ SWP/ 169430/2012)).
Are your PDE reports up to date?