Legal framework

The radiopharmaceutical service at INM-5 produces sterile solutions of radiotracers (Parentaralia) for applications in human medicine.

The radiotracers produced at INM-5 consist exclusively of organic molecules that are labeled with positron emitters. After application to humans or animals, their annihilation radiation is recorded by the ring-shaped detectors of a positron emission tomograph (PET) and combined into a distribution image using imaging techniques. This imaging method allows biochemical and physiological processes in the living body to be recorded externally with high spatial and temporal resolution without influencing these processes themselves.

The manufacture of radioactive medicinal products is subject to the rules of GMP (Good Manufacturing Practice), which are required by laws and regulations (German Medicinal Products Act (AMG), German Ordinance on the Manufacture of Medicinal Products and Active Pharmaceutical Ingredients (AMWHV)) and formulated in guidelines (EC GMP). The Research Center has a manufacturing authorization for radioactive medicinal products in accordance with § 13 AMG issued by the Cologne District Government.

At INM-5, a total of five competent persons have been appointed by the supervisory authority (Cologne district government). From this group of persons, both a Head of Production and a Head of Quality Control and their respective deputies have been appointed (see organization chart).

In addition, the radiopharmaceutical service is monitored by a quality assurance unit consisting of the QM representative of the INM-5 and two non-INM employees of the FZJ who carry out internal audits.

The Radiation and Occupational Safety department is also assigned to an INM-5 employee. Accompanying research and development work is also carried out there to improve the product quality of the radiopharmaceutical service.