Health-based exposure limits and toxicology in the pharmaceutical industry

Abstract Cross-contamination is inevitable when it comes to the production of different products in the same manufacturing facility. For decades, many different approaches have been suggested and applied by regulators and institutions to control the risk of cross-contamination in shared facilities. Empirical methods have been replaced by the determination of health-based exposure limits in recent years. This innovation has resulted in toxicological risk assessment being included in manufacturing processes. With the determination of the permitted daily exposure (PDE) value, which includes a very comprehensive scientific evaluation, it is expected that no health risks will occur at this level. Harmonization and standardization in this process will provide significant benefits to increase the quality of the reports. The aim of this chapter is to provide a basic understanding for the PDE determination strategy.