ABSTRACT

Radiopharmaceutical products are inorganic compounds, organic compounds, peptides, proteins, monoclonal antibodies and fragments, and oligonucleotides labeled with radionuclides whose half-life ranges from a few minutes to several days. These radioactive isotopes used for various medical purposes decay spontaneously under ionizing radiation emission. Radiopharmaceuticals cover a wide range of procedures including diagnostics [single photon emission computed tomography (SPECT); and positron emission tomography (PET)], radiation therapy (oncology and palliative pain management), as well as early clinical research and radiolabeled molecule development (e.g. pharmacokinetics, metabolism, receptor binding studies) covers a range of procedures. Unlike conventional medicinal products, RP does not induce pharmacodynamic effects, as small amounts of active ingredients are usually used. Radiopharmaceuticals are classified as medicinal products and therefore they form the basis of the same regulations as non-radioactive medicinal products. In addition to pharmaceutical legislation, laws relating to the manufacture, supply or use of radioactive medicinal products that aim to protect employees, the general public and the environment from radiation need to be followed. The main purpose in good radiopharmacy applications is the safety of the product for medical products and the safety of the patient to whom the product is applied, together with the radiation protection rules. This guide aims to provide an overview of the minimum Good Radiopharmacy Practices (GRP) requirements for radiopharmaceuticals. The manual can also be used as training material for practice, quality control and quality assurance personnel in the field.