- We have Expertise in calculating PDE/OEL for cleaning validation processes and provide Permitted Daily Exposure (PDE) report & Occupational Exposure Limit (OEL) value.
- Report are made in line with “Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities” and “ICH Q3C (R4) Impurities and Annex 3 of VICH GL 18 and based on a structured scientific evaluation with all available pharmacological and toxicological data including non-clinical and clinical data.
- We elaborate PDE monographs with all calculation details and all bibliographic references linked to this calculations by complete reviewing of all relevant pharmaceutical and medical databases.