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

Nic Gillings,Peter Laverman,Valentina Ferrari,Olaug Hjelstuen,Oliver Neels,Jacek Koziorowski,Clemens Decristoforo,Meltem Ocak,Sergio Todde,Martin Behe,Jim Ballinger,Thomas L Mindt,Marianne Patt,Philip Elsinga,Petra Kolenc Peitl

doi:10.1186/s41181-021-00123-2

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.

Highlights

The preparation and use of radiopharmaceuticals in the European Union are regulated by directives, regulations and rules that have been adopted by member states
The last two decades have seen the impact of the implementation of the European Clinical Trials Directive (EU Commission, 2001) with its requirement for Good Manufacturing Practice (GMP) in the preparation of radiopharmaceuticals for use in clinical trials
This revision takes into account recent documents related to Good Radiopharmacy Practices such as the PIC/S guide to good practices for the preparation of medicinal products in healthcare establishments, with Annex 3 describing radiopharmaceuticals (PIC/S Guide to good practices for the preparation of medicinal products in healthcare establishments, 2014) and relevant chapters in the European Pharmacopoeia (European Pharmacopoeia, 2016; European Pharmacopoeia, 2016)

Summary

Introduction

The preparation and use of radiopharmaceuticals in the European Union are regulated by directives, regulations and rules that have been adopted by member states.

Results

Conclusion