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

TY - JOUR

T1 - Guideline on current good radiopharmacy practice (cGRPP) for the small-scale preparation of radiopharmaceuticals

AU - Gillings, Nic

AU - Hjelstuen, Olaug

AU - Ballinger, Jim

AU - Behe, Martin

AU - Decristoforo, Clemens

AU - Elsinga, Philip

AU - Ferrari, Valentina

AU - Peitl, Petra Kolenc

AU - Koziorowski, Jacek

AU - Laverman, Peter

AU - Mindt, Thomas L.

AU - Neels, Oliver

AU - Ocak, Meltem

AU - Patt, Marianne

AU - Todde, Sergio

N1 - Publisher Copyright: © 2021, The Author(s). Copyright: Copyright 2021 Elsevier B.V., All rights reserved.

PY - 2021/12

Y1 - 2021/12

N2 - 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.

AB - 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.

KW - cGRPP

KW - GMP

KW - Radiopharmaceuticals

KW - Radiopharmacy

UR - http://www.scopus.com/inward/record.url?scp=85102603114&partnerID=8YFLogxK

U2 - 10.1186/s41181-021-00123-2

DO - 10.1186/s41181-021-00123-2

M3 - Article

AN - SCOPUS:85102603114

SN - 2365-421X

VL - 6

JO - EJNMMI Radiopharmacy and Chemistry

JF - EJNMMI Radiopharmacy and Chemistry

IS - 1

M1 - 8

ER -