This guideline on current good radiopharmacy practice (cGRPP) for small-scale preparation of radiopharmaceuticals represents the view of the Radiopharmacy Committee of the European Association of Nuclear Medicine (EANM). The guideline is laid out in the format of the EU Good Manufacturing Practice (GMP) guidelines as defined in EudraLex volume 4. It is intended for non-commercial sites such as hospital radiopharmacies, nuclear medicine departments, research PET centres and in general any healthcare establishments. In the first section, general aspects which are applicable to all levels of operations are discussed. The second section discusses the preparation of small-scale radiopharmaceuticals (SSRP) using licensed generators and kits. Finally, the third section goes into the more complex preparation of SSRP from non-licensed starting materials, often requiring a purification step and sterile filtration. The intention is that the guideline will assist radiopharmacies in the preparation of diagnostic and therapeutic SSRP’s safe for human administration.

Gillings, N., Hjelstuen, O., Ballinger, J., Behe, M., Decristoforo, C., Elsinga, P., et al. (2021). Guideline on current good radiopharmacy practice (cGRPP) for the small-scale preparation of radiopharmaceuticals. EJNMMI RADIOPHARMACY AND CHEMISTRY, 6(1), 8 [10.1186/s41181-021-00123-2].

Guideline on current good radiopharmacy practice (cGRPP) for the small-scale preparation of radiopharmaceuticals

Todde S.
2021

Abstract

This guideline on current good radiopharmacy practice (cGRPP) for small-scale preparation of radiopharmaceuticals represents the view of the Radiopharmacy Committee of the European Association of Nuclear Medicine (EANM). The guideline is laid out in the format of the EU Good Manufacturing Practice (GMP) guidelines as defined in EudraLex volume 4. It is intended for non-commercial sites such as hospital radiopharmacies, nuclear medicine departments, research PET centres and in general any healthcare establishments. In the first section, general aspects which are applicable to all levels of operations are discussed. The second section discusses the preparation of small-scale radiopharmaceuticals (SSRP) using licensed generators and kits. Finally, the third section goes into the more complex preparation of SSRP from non-licensed starting materials, often requiring a purification step and sterile filtration. The intention is that the guideline will assist radiopharmacies in the preparation of diagnostic and therapeutic SSRP’s safe for human administration.
Articolo in rivista - Articolo scientifico
cGRPP; GMP; Radiopharmaceuticals; Radiopharmacy;
English
8
Gillings, N., Hjelstuen, O., Ballinger, J., Behe, M., Decristoforo, C., Elsinga, P., et al. (2021). Guideline on current good radiopharmacy practice (cGRPP) for the small-scale preparation of radiopharmaceuticals. EJNMMI RADIOPHARMACY AND CHEMISTRY, 6(1), 8 [10.1186/s41181-021-00123-2].
Gillings, N; Hjelstuen, O; Ballinger, J; Behe, M; Decristoforo, C; Elsinga, P; Ferrari, V; Peitl, P; Koziorowski, J; Laverman, P; Mindt, T; Neels, O; Ocak, M; Patt, M; Todde, S
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/10281/354722
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