Medicinal Products

During the manufacturing of a medicinal product specific toxicological expertise is needed on different stages for different purposes:
  • Preparation of dossiers for the authorization (CTD modul 2.4 and 2.5)
  • Derivation of a PDE-value (Permitted Daily Exposure), which is a crucial parameter for the cleaning validation.
  • Safety of the workers by deriving an adequate and defendable OEL (Occupational Exposure Limit).
  • Implementation of the relevant guidelines for impurities in medicinal products (ICH Q3C and ICH Q3D).
  • Evaluation of substances, which may migrate from packaging material or manufacturing equipment into the medicinal product. This includes the full evaluation of testing results for extractable and leachable substances.

The toxicological expertise is supported by a particular understanding of the pharmaceutical industry due to the background as pharmacist.