(2003; 148 pages)
Radiopharmaceuticals must be manufactured in accordance with the basic principles of good manufacturing practices (GMP). The matters covered by these guidelines should therefore be considered as supplementary to the general requirements for GMP previously published (1,2) and relate specifically to the production and control of radiopharmaceuticals. In the preparation of these guidelines, due consideration was given to national or international radiation safety guidelines (4).
Because of their short half-lives, many radiopharmaceuticals are released and administered to patients shortly after their production, so that quality control may sometimes be retrospective. Strict adherence to GMP is therefore mandatory.