Being the manufacturers of a variety of medicinal products in shared facilities, it is customatory for Pharmaceutical industry to implement the guidelines of European Medicines Agency (EMA) with regards to Health Based Exposure Limits (HBEL) to prevent toxicological risk.
One such threshold value: permitted daily exposure (PDE) or threshold of toxicological concern (TTC) should be the result of a systematic and critical scientific evaluation of all available pharmacological and toxicological data including both non-clinical and clinical reports of that specific substance/compound.