Specialists of the State Expert Center of the Ministry of Health of Ukraine have for the first time in Ukraine developed the methodological recommendations "Good Radiopharmacy Practice (GRPP) for the small-scale preparation of radiopharmaceuticals".
The document was developed on the basis of the guideline of the European Association of Nuclear Medicine (EANM) "Guideline on current good radiopharmacy practice (cGRPP) for the small-scale preparation of radiopharmaceuticals (2021)" and the current regulatory framework.
The purpose is to ensure the quality and safety of the preparation of radiopharmaceuticals through harmonized standards and special rules, taking into account the particular needs of this practice exclusively in the interests of patients.
The recommendations were created to assist radiopharmacy institutions in the preparation of diagnostic and therapeutic small-scale radiopharmaceuticals of their own manufacture that are not intended for commercial purposes or distribution.
The document describes the requirements for non-commercial in-house preparation of radiopharmaceuticals for direct use in accordance with European and national legislation, including "assembly" using both registered/licensed starting materials (with authorization for the use of radioactive substances) and unregistered/unlicensed starting materials (without authorization for circulation).
For more details, the text of the methodological recommendations can be found on the Center's website at the following link:
DOCXFor the first time in Ukraine, methodological recommendations on good radiopharmacy practice (GRPP) have been developedDOCX · 124 KB
For information, radiopharmaceuticals are a special type of medicinal product containing radioactive isotopes. They are widely used throughout the world in the field of oncology, as well as for the diagnosis of cardiac, neurological and other types of diseases.
