EANM guideline on quality risk management for radiopharmaceuticals

Nic Gillings; Olaug Hjelstuen; Martin Behe; Clemens Decristoforo; Philip H Elsinga; Valentina Ferrari; Oliver C Kiss; Petra Kolenc; Jacek Koziorowski; Peter Laverman; Thomas L Mindt; Meltem Ocak; Marianne Patt; Sergio Todde; Almut Walte

doi:10.1007/s00259-022-05738-4

EANM guideline on quality risk management for radiopharmaceuticals

Eur J Nucl Med Mol Imaging. 2022 Aug;49(10):3353-3364. doi: 10.1007/s00259-022-05738-4. Epub 2022 Apr 7.

Authors

Nic Gillings¹, Olaug Hjelstuen², Martin Behe³, Clemens Decristoforo⁴, Philip H Elsinga⁵, Valentina Ferrari⁶, Oliver C Kiss⁷, Petra Kolenc⁸, Jacek Koziorowski⁹, Peter Laverman¹⁰, Thomas L Mindt¹¹, Meltem Ocak¹², Marianne Patt¹³, Sergio Todde¹⁴, Almut Walte¹⁵

Affiliations

¹ Department of Clinical Physiology and Nuclear Medicine, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.
² GE Healthcare, Pharmaceutical Diagnostics, Oslo, Norway.
³ Center for Radiopharmaceutical Sciences, Paul Scherrer Institute, Villigen, Switzerland.
⁴ Department of Nuclear Medicine, Medical University Innsbruck, Innsbruck, Austria.
⁵ Department of Nuclear Medicine and Molecular Imaging, University Medical Center Groningen, Groningen, The Netherlands.
⁶ MSD Animal Health, Milton Keynes, UK.
⁷ Department of Radiopharmaceuticals Production, Institute for Radiopharmaceutical Cancer Research, Helmholtz-Zentrum Dresden-Rossendorf, Dresden, Germany. [email protected].
⁸ Department of Nuclear Medicine and Faculty of Pharmacy, University Medical Centre Ljubljana and University of Ljubljana, Ljubljana, Slovenia.
⁹ Independent Consultant, Linköping, Sweden.
¹⁰ Department of Medical Imaging, Nuclear Medicine, Radboud University Medical Center Nijmegen, Nijmegen, The Netherlands.
¹¹ Ludwig Boltzmann Institute Applied Diagnostics, Vienna, Austria.
¹² Department of Pharmaceutical Technology, Istanbul University, Istanbul, Turkey.
¹³ Department for Nuclear Medicine, University Hospital Leipzig, Leipzig, Germany.
¹⁴ Tecnomed Foundation, University of Milano-Bicocca, Monza, Italy.
¹⁵ Department of Nuclear Medicine, Hannover Medical School, Hanover, Germany.

Abstract

This document is intended as a supplement to the EANM "Guidelines on current Good Radiopharmacy Practice (cGRPP)" issued by the Radiopharmacy Committee of the EANM (Gillings et al. in EJNMMI Radiopharm Chem. 6:8, 2021). The aim of the EANM Radiopharmacy Committee is to provide a document that describes how to manage risks associated with small-scale "in-house" preparation of radiopharmaceuticals, not intended for commercial purposes or distribution.

Keywords: Quality assurance; Radiopharmaceuticals; Risk assessment.

MeSH terms

Humans
Nuclear Medicine*
Radiopharmaceuticals* / adverse effects
Risk Management

Substances

Radiopharmaceuticals