QUALITY ASSURANCE AND QUALITY CONTROL OF RADIOPHARMACEUTICALS: AN OVERVIEW

Abstract

Objective: Radiopharmacy is a special field of pharmacy that examines, develops, conducts quality controls, deals with distribution and application of pharmaceutical forms called radiopharmaceuticals that are used for diagnostic and therapeutic purposes, carrying pharmaceutical and radioactive properties together. Radiopharmaceuticals contain radionuclides. This is the most important difference that distinguishes radiopharmaceuticals from other conventional drugs. Since radiopharmaceuticals are administered to humans, they must be sterile, pyrogen-free, isotonic, isohydric, and subject to all quality control tests required for conventional drug. Also, additional quality control tests are required due to radionuclide they contain. In this review, quality control tests applied to radiopharmaceuticals, hospital radiopharmacy laboratory types and Good Radiopharmacy Practices (GRP) will be discussed. Result and Discussion: Radiopharmaceuticals should be prepared in accordance with standards specified in relevant sections of pharmacopoeias. For each series of radiopharmaceuticals, tests prescribed in the pharmacopoeias and records must be kept. Production and preparation of radiopharmaceuticals should be carried out in accordance with Good Manufacturing Practices for sterile preparations and GRP for radioactive products. However, radiopharmaceuticals that pass quality control tests can be administered to patients after dose measurements are made in dose calibrators. Thus, the patient's safety and benefit are maximized, while the risk is minimized. Some radiopharmaceuticals with a short half-life are used before quality control tests are completed. In this case, the effectiveness and continuation of the quality assurance system should be tested at appropriate intervals. According to procedures performed by hospital radiopharmacy laboratories, international standards are determined as Level IA/B, Level IIA/B and Level IIIA/B/C. Quality assurance of radiopharmaceuticals is provided by a sufficient number of trained personnel within the scope of GRP, devices that have been calibrated and controlled, appropriate substances and a working order in which tests determined at each stage are made and results are recorded accurately and regularly.