A Review on Good Manufacturing Practices for Radiopharmaceuticals

According to WHO, they are classified as Ready-for-use radioactive products, Radionuclide generators, Non-radioactive components (kits) for the preparation of labelled compounds with a radioactive component and Precursors used for radiolabelling other substances before administration they are classified into three groups: Preparations which are supplied as a radioactively-labelled product in a ready- to-inject form, Inactive products which are made radioactive immediately prior to patient injection and Radionuclide preparations that are combined with an inactive preparation to produce the final product for injection. They are characterized by their chemical and physicochemical properties and by the radiation properties of the radionuclide which they contain. Radiopharmaceuticals consist of pharmaceutical component as well as radioactive component Radiopharmaceuticals are considered a safe class of agents, in part due to the small chemical quantities administered in most cases. However, if a study had to be repeated because of a poor quality radiopharmaceutical, the patient would receive an unnecessary radiation dose with useless consequences. The preparation of radiopharmaceuticals is generally reliable .The reliability of radiopharmaceuticals depends on both, the design of preparation procedures (e.g. generators and kits, automated synthesis units) and quality control measures before release