PET radiopharmaceutical production - a unit of preparation and quality control

The view on the production of radiopharmaceuticals for human use in Positron Emission Tomography (PET) has been changing considerably during the last few years. PET has developed from an elitist research method only to a tool covering the research purpose as well the clinical application.
Accordingly, the radioactive substances which have been applied as radiotracers underwent a transformation to radiopharmaceuticals. This is accompanied by the transfer of the pharmaceutical legislation to PET radiopharmaceuticals. Consequently, Marketing and Manufacturing Authorisation becomes more and more important for the production of PET radiopharmaceuticals. To get the manufacturing Authorisation the manufacturer has to apply the guidelines of Good Manufacturing Practise (GMP) by consideration of monographs in pharmacopoeia.
In the lecture, the translation of the GMP regulations to the manufacturing conditions of PET radiopharmaceuticals is presented. This is illustrated by the example of the Rossendorf PET-Centre.