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European Journal of Nuclear Medicine and Molecular Imaging
Published in: European Journal of Nuclear Medicine and Molecular Imaging 10/2022

Open Access 07-04-2022 | Guidelines

EANM guideline on quality risk management for radiopharmaceuticals

Authors: 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

Published in: European Journal of Nuclear Medicine and Molecular Imaging | Issue 10/2022

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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.
Appendix
Available only for authorised users
Literature
1.
EudraLex Volume 4 - Good Manufacturing Practice (GMP) guidelines, Part I “Basic Requirements for Medicinal Products”, current version.
2.
EudraLex Volume 4 – Good Manufacturing Practice (GMP) guidelines, Part II “Basic Requirements for Active Substances used as Starting Materials”, current version.
3.
EudraLex Volume 4 - Good Manufacturing Practice (GMP) guidelines, Part III “GMP-related documents”, current version.
4.
Eudralex Volume 4, GMP, Annex 1 “Manufacture of Sterile Medicinal Products”, current version.
5.
Eudralex Volume 4, GMP, Annex 3 “Manufacture of Radiopharmaceuticals”, current version.
6.
Eudralex Volume 4, GMP, Annex 11 “Computerised Systems”, current version.
7.
Eudralex Volume 4, GMP, Annex 13 “Investigational Medicinal Products”, current version.
8.
Eudralex Volume 4, GMP, Annex 15 “Qualification and Validation”, current version.
9.
European Pharmacopoeia, current version, chapter 5.19 “Extemporaneous preparation of radiopharmaceuticals”.
10.
ICH Q9 Quality Risk Management, current version.
11.
International standard IEC 60812, “Analysis techniques for system reliability – procedure for failure mode and effects analysis (FMEA), current version.
12.
Kotzerke J, Fetzer P, Grosche-Schlee S, Hanel A, Freudenberg R, Brogsitter C. Development of a system for risk analysis in treatment with unsealed radioactive substances in nuclear medicine. Nuklearmedizin. 2020;59:60–78.CrossRef
13.
Todde S, Kolenc Peitl P, Elsinga P, Koziorowski J, Ferrari V, Ocak EM, Hjelstuen O, Patt M, Mindt TL, Behe M. Guidance on validation and qualification of processes and operations involving radiopharmaceuticals. EJNMMI Radiopharm Chem. 2017;2:8.CrossRef
14.
Gillings N, Hjelstuen O, Ballinger J, Behe M, Decristoforo C, Elsinga P, Ferrari V, Kolenc Peitl P, Koziorowski J, Laverman P, Mindt TL, Neels O, Ocak M, Patt M, Todde S. Guideline on current good radiopharmacy practice (cGRPP) for the small-scale preparation of radiopharmaceuticals. EJNMMI Radiopharm Chem. 2021;6:8.CrossRef
Metadata
Title
EANM guideline on quality risk management for radiopharmaceuticals
Authors
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
Publication date
07-04-2022
Publisher
Springer Berlin Heidelberg
Published in
European Journal of Nuclear Medicine and Molecular Imaging / Issue 10/2022
Print ISSN: 1619-7070
Electronic ISSN: 1619-7089
DOI
https://doi.org/10.1007/s00259-022-05738-4

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