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Quality Control in the Production of Radiopharmaceuticals

IAEA TECDOC No. 1856
English IAEA-TECDOC-1856 978-92-0-107918-3
148 5 18.00 2018

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Description

Advances have led to the production of new radiopharmaceuticals and availability of new production routes. Various new diagnostic agents in the field (such as Ga-68 radiopharmaceuticals and generators) as well as therapeutic agents (such as alpha emitters) have been added to the clinician’s menu. It is essential that radiopharmaceuticals are prepared within a robust quality control system encompassing materials and personnel, with adequate documentation, and continuous review of ongoing results. This publication provides guidelines and best practices for the quality control of medical radioisotopes and radiopharmaceuticals. It was written by a group of experts with experience across a range of radiopharmaceuticals and is intended to support professionals in the preparation of good quality and safe products to be used in nuclear medicine procedures.

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Keywords

Nuclear Medicine, Radiopharmaceuticals, Pharmaceutical Industry, Quality Control, Radioisotopes in Pharmacology, Radionuclides, Best Practices, Medical Radioisotopes, Production, Member States, Validation, Equipment, Instruments, Techniques, Protocols, Legislation, Training, Personnel, Quality Control Assays, Diagnosis, Therapeutic Applications, Methods, Countries, Regions, North America, South America, Asia, Russia, Quality Assurance, Gamma Spectrometry, Starting Materials, Radiochemical Purity, Chemical Purity, Osmolality, Dose, Chromatography, Method Qualification, Testing, Safety Considerations, Out of Specification, GMP, Good Manufacturing Practice, Radionuclidic Purity, SOP, Standard Operating Procedures, Specific Activity, Therapeutic Agents

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