Radiopharmacy/Radiochemistry for Positron-Emitting Radiopharmaceuticals, Including Quality Assurance and Process Validat
Inclusion of radiopharmaceuticals into the family of medicinal products, and compliance with regulations thereof, has not been homogeneous worldwide, as the process has occurred with different chronologies and different strategies have been adopted across
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Piero A. Salvadori
Contents 40.1 The Regulatory Framework of PET Radiopharmaceuticals
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40.2 The Approved Radiopharmaceuticals......
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40.3 In-House Preparations for Clinical Use...
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40.4 In-House Radiopharmacy Layout............
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40.5 Radioactive Precursors
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40.6 Radiopharmaceutical Process
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40.7 Final Solution Checking and Control......
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40.8 Quality and Product Release
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Further Reading
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Learning Objectives
• Provide an overview on rules and regulations applicable to PET radiopharmaceuticals. • Explain differences in use and regulations between approved radiopharmaceuticals (i.e., with a marketing authorization) and those prepared in-house. • Describe the basic criteria of radiopharmacy layout design. • Provide an outline of the good manufacturing practice and quality requirements to be adopted in a site dedicated to radiopharmaceutical production. • Describe the steps and related main issues of a radiopharmaceutical production process. • Provide an overview on adopted technologies and practical solutions in PET radiopharmacy. • Provide basic information on quality control and product release of PET radiopharmaceuticals.
P. A. Salvadori (*) PET/Cyclotron Unit, CNR Institute of Clinical Physiology, Pisa, Italy e-mail: [email protected]
40.1 T he Regulatory Framework of PET Radiopharmaceuticals Inclusion of radiopharmaceuticals into the family of medicinal products, and compliance with regulations thereof, has not been homogeneous worldwide, as the process has occurred with different chronologies and different strategies have been adopted across countries. However, general consensus has been reached on the medicinal nature of these products and on the notion that their use in humans must be done in compliance with enforced regulations. In some specific instances, such as during clinical investigations and when using non-approved radiopharmaceuticals, their application may be severely limited. The radioactive nature and the technology needed to perform a PET scan have conveyed the use of PET radiopharmaceuticals to hospitals and medical centers. Despite their short half-life, PET radiopharmaceuticals may be made available to users through commercial sources, and many manufacturers even ship PET tracers across borders between different countries. Nevertheless, despite a quite diffuse and efficient distribution network of PET radiopharmaceuticals, in-house preparation and compounding is still largely present. Furthermore, in many countries the distribution off-site
© Springer Nature Switzerland AG 2019 D. Volterrani et al. (eds.), Nuclear Medicine Textbook, https://doi.org/10.1007/978-3-319-95564-3_40
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of in-house preparations of PET tracers may also be possible, so that two separate logistical/distribution circuits exist for supply of the radiolabeled products. In general, manufacturing and compounding must follow different regulations. Almost anywhere, manufacturing is based on a quality assurance system es
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