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Regulatory framework

Production

In the domain of the radiopharmaceutical services of the INM-5 sterile solutions of radiotracers are produced for application in human medicine. These radiotracers are exclusively organic molecules labelled with positron emitters.

After application to human or animal the annihilation radiation of the positron is detected by an array of detectors of a Positron Emission Tomograph (PET). PET measures the radioactivity distribution in the target organ, a computer calculates the corresponding images and metabolic activity. Biochemical and physiological processes in the living body can be observed with a high spatial and temporal resolution using this imaging technique without influencing these processes.

The production of radiopharmaceuticals is in accordance with the rules of GMP (Good manufacturing practice), which is a demand of the German drug law (Arzneimittelgesetz, AMG) and German drug regulations (e.g. Arzneimittel- und Wirkstoffherstellungsverordnung (AMWHV)) and is formulated in European regulations (EUDRALEX Volume 4 - Medicinal Products for Human and Veterinary Use: Good Manufacturing Practice).  The Research Centre Jülich is in possession of a manufacturing authorisation for medicinal products (§ 13 AMG) issued by the Bezirksregierung Köln.

Five "Qualified persons" are appointed by the regional regulatory authority (Bezirksregierung Köln) who are divided into a head of Production and a head of Quality Control and their corresponding substitutes.

Furthermore, the radiopharmaceutical services are controlled by a quality assurance unit consisting of a Quality management representative of the INM-5 and two non-INB members of  the Research Centre. They perform internal audits.

A staff member of INM-5 is also designated to radiation protection, health and safety at the workplace.


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