(2003; 148 pages)
1. Scope of these guidelines
These guidelines are intended to complement those already available for pharmaceutical products (1,2) as well as those for sterile pharmaceutical products (3).
The regulatory procedures necessary to control radiopharmaceutical products are in large part determined by the sources of these products and the methods of manufacture. Manufacturing procedures within the scope of these guidelines include:
• The preparation of radiopharmaceuticals in hospital radio-pharmacies.
• The preparation of radiopharmaceuticals in centralized radio-pharmacies.
• The production of radiopharmaceuticals in nuclear centres and institutes or by industrial manufacturers.
• The preparation and production of radiopharmaceuticals in positron emission tomography (PET) centres.
Radiopharmaceuticals can be classified into four categories:
1. Ready-for-use radioactive products.
2. Radionuclide generators.
3. Non-radioactive components (“kits”) for the preparation of labelled compounds with a radioactive component (usually the eluate from a radionuclide generator).
4. Precursors used for radiolabelling other substances before administration (e.g. samples from patients).
Radiopharmaceutical products include inorganic compounds, organic compounds, peptides, proteins, monoclonal antibodies and fragments, and oligonucleotides labelled with radionuclides with half-lives from a few seconds to several days.