Gillings Nic, Hjelstuen Olaug, Ballinger Jim, Behe Martin, Decristoforo Clemens, Elsinga Philip, Ferrari Valentina, Peitl Petra Kolenc, Koziorowski Jacek, Laverman Peter, Mindt Thomas L, Neels Oliver, Ocak Meltem, Patt Marianne, Todde Sergio
Department of Clinical Physiology, Nuclear Medicine and PET, Copenhagen University Hospital Rigshospitalet, Blegdamsvej 9, DK-2100, Copenhagen, Denmark.
GE Healthcare, Pharmaceutical Diagnostics, Oslo, Norway.
EJNMMI Radiopharm Chem. 2021 Feb 12;6(1):8. doi: 10.1186/s41181-021-00123-2.
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.
本关于小规模制备放射性药物的现行良好放射性药物操作规范（cGRPP）指南代表了欧洲核医学协会（EANM）放射性药物委员会的观点。该指南采用了欧盟药品生产质量管理规范（GMP）指南的格式，如《欧洲药典》第4卷所定义。它适用于非商业场所，如医院放射性药房、核医学科、研究性PET中心以及一般的任何医疗机构。在第一部分，讨论了适用于各级操作的一般方面。第二部分讨论了使用许可的发生器和试剂盒制备小规模放射性药物（SSRP）。最后，第三部分深入探讨了从非许可起始原料制备SSRP的更复杂过程，这通常需要纯化步骤和无菌过滤。目的是该指南将协助放射性药房制备对人体给药安全的诊断和治疗性SSRP。
