ABSTRACT

Radiopharmaceutical products are classified as specialty medicinal products containing radionuclides whose half-lives range from a few minutes to several days, and therefore they form the basis of the same regulations as non-radioactive medicinal products. Radiopharmaceuticals should be manufactured in accordance with the basic principles of good manufacturing practice (GMP). Therefore, as complementary to the GMP general requirements for pharmaceutical products, it is particularly relevant to the production and control of radiopharmaceuticals. Due to their short half-life, many radiopharmaceuticals are placed on the market shortly after they are manufactured and administered to patients, so quality control can sometimes be retrospective. Therefore, strict adherence to GMP is imperative. These guidelines are intended to provide an overview of minimum GMP requirements for radiopharmaceuticals. The manual can also be used as training material for production, quality control and quality assurance personnel in the industry as well as inspectors.