ABSTRACT

Quality control (QC) and quality assurance (QA) concepts should be included in a system framework in every area where production and/or service is located. In health applications, while QA is valid and vital for all conventional drug classes; there are many special cases for QA of radioactive elements, which are defined as radiopharmaceuticals, can be used for diagnostic and/or therapeutic purposes, but do not cause any change in humans after administration. QA in radiopharmacy is critical for practice. A poor-quality diagnostic radiopharmaceutical, while not in itself unsafe, it could give incorrect information about the patient’s condition leading to an inappropriate choice of therapy. A poor-quality therapeutic radiopharmaceutical could lead to excess radiation exposure to non-target tissues along with reduced efficacy. The short physical half-lives of the radionuclides cause logistical difficulties with time constraints to ensure QC of radiopharmaceuticals earlier than the product’s release for use. On the other hand, QA when evaluating the product/service quality control; it consists of a system that covers the entire process, including all documents for security, efficiency, and security. Therefore, for QA in radiopharmaceuticals, it is essential that radiopharmaceuticals are prepared within an effective QA system that includes material and ventilation controls, appropriate documentation, and ongoing review of ongoing results. Such a system should include QC of starting systems used in production, QC of radionuclides and radiopharmaceuticals, maintenance of equipment used, validation of methods, equipment and method qualification and safety considerations. In this review, with the evaluations made within the scope of these basic elements, it is mostly aimed to create a resource that professionals in the field of radiopharmacy can benefit from during the production of medical radioisotopes and radiopharmaceuticals for diagnostic and therapeutic use within a safe quality system.