ZytoCheck – Development of Reference Methods for the Non-Destructive Testing of Cytostatic Infusions

Description:

Cytostatic drugs and immunotherapeutics are frequently used to treat cancer. The therapeutic dose must be individually adjusted for each patient to ensure optimal treatment. Specially trained pharmacy staff are responsible for the patient-specific preparation of the medication.

Quality control in the manufacturing pharmacies is regulated by the Pharmacy Distribution Regulations. Random inspections by the competent authorities show that the preparations are rarely found to be non-compliant. Nevertheless, errors or instances of tampering cannot be completely ruled out.

Instrumental-analytical quality control to confirm the content and identity of the active ingredient in the prepared infusion bags is currently not standardized.

Within the framework of the ZytoCheck project, a non-destructive method for on-site testing of parenteral preparations is therefore to be developed that confirms and documents the proper preparation for manufacturing pharmacies at a reasonable economic cost.