Abstract
AbstractThis 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.
Publisher
Springer Science and Business Media LLC
Subject
Pharmacology (medical),Pharmacology,Radiology, Nuclear Medicine and imaging,Analytical Chemistry
Reference20 articles.
1. Aerts J, Ballinger JR, Behe M, Decristoforo C, Elsinga PH, Faivre-Chauvet A, Mindt TL, Kolenc Peitl P, Todde S, Koziorowski J. Guidance on current good radiopharmacy practice for the small-scale preparation of radiopharmaceuticals using automated modules: a European perspective. J Labelled Compd Radiopharm. 2014;57:615–20.
2. de Vries EJF, Roca M, Jamar F, Israel O, Signore A. Guidelines for the labelling of leucocytes with 99mTc-HMPAO. Eur J Nucl Med Mol Imaging. 2010;37:842–8.
3. EANM Guideline on “Quality Risk Management guidelines applied to radiopharmaceuticals”. In preparation. 2021.
4. EANM Guidelines on Current good radiopharmacy practice (cGRPP) in the preparation of radiopharmaceuticals. Version 2, March 2007. https://www.eanm.org/publications/guidelines/gl_radioph_cgrpp.pdf. Accessed 30 April 2020.
5. Elsinga P, Todde S, Penuelas I, Meyer G, Farstad B, Faivre-Chauvet A, Mikolajczak R, Westera G, Gmeiner-Stopar T, Decristoforo C. Guidance on current good radiopharmacy practice (cGRPP) for the small-scale preparation of radiopharmaceuticals. Eur J Nucl Med Mol Imaging. 2010;37(5):1049–62.
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