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

被引:65
作者
Gillings, Nic [1 ]
Hjelstuen, Olaug [2 ]
Ballinger, Jim [3 ]
Behe, Martin [4 ]
Decristoforo, Clemens [5 ]
Elsinga, Philip [6 ]
Ferrari, Valentina [7 ]
Peitl, Petra Kolenc [8 ]
Koziorowski, Jacek
Laverman, Peter [9 ]
Mindt, Thomas L. [10 ]
Neels, Oliver [11 ]
Ocak, Meltem [12 ]
Patt, Marianne [13 ]
Todde, Sergio [14 ]
机构
[1] Copenhagen Univ Hosp, Rigshosp, Dept Clin Physiol Nucl Med & PET, Blegdamsvej 9, DK-2100 Copenhagen, Denmark
[2] GE Healthcare, Pharmaceut Diagnost, Oslo, Norway
[3] Kings Coll London, Div Imaging Sci & Biomed Engn, London, England
[4] Paul Scherrer Inst, Ctr Radiopharmaceut Sci, Villigen, Switzerland
[5] Med Univ Innsbruck, Dept Nucl Med, Innsbruck, Austria
[6] Univ Med Ctr Groningen, Dept Nucl Med & Mol Imaging, Groningen, Netherlands
[7] MSD Anim Hlth, Milton Keynes, Bucks, England
[8] Univ Med Ctr Ljubljana, Ljubljana, Slovenia
[9] Radboud Univ Nijmegen, Med Ctr Nijmegen, Nijmegen, Netherlands
[10] Ludwig Boltzmann Inst Appl Diagnost, Vienna, Austria
[11] Helmholtz Zentrum Dresden Rossendorf, Inst Radiopharmaceut Canc Res, Dresden, Germany
[12] Istanbul Univ, Dept Pharmaceut Technol, Istanbul, Turkey
[13] Univ Hosp Leipzig, Dept Nucl Med, Leipzig, Germany
[14] Univ Milano Bicocca, Tecnomed Fdn, Milan, Italy
关键词
cGRPP; GMP; Radiopharmaceuticals; Radiopharmacy;
D O I
10.1186/s41181-021-00123-2
中图分类号
R914 [药物化学];
学科分类号
100701 ;
摘要
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.
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页数:22
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