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진단용 방사성의약품의 품질관리시험 및 기준

Other Titles
 Quality Control Tests and Acceptance Criteria of Diagnostic Radiopharmaceuticals 
 Korean Journal of Clinical Laboratory Science, Vol.53(1) : 1-10, 2021-03 
Journal Title
 Korean Journal of Clinical Laboratory Science 
Issue Date
Good manufacturing practice ; Quality control ; Radiopharmaceuticals
Radiopharmaceuticals are drugs that contain radioisotopes and are used in the diagnosis, treatment, or investigation of diseases. Radiopharmaceuticals must be manufactured in compliance with good manufacturing practice regulations and subjected to quality control before they are administered to patients to ensure the safety of the drug. Radiopharmaceuticals for administration to humans need to be sterile and pyrogen-free. Hence, sterility tests and membrane filter integrity tests are carried out to confirm the asepticity of the finished drug product, and a bacterial endotoxin test conducted to assess contamination, if any, by pyrogens. The physical appearance and the absence of foreign insoluble substances should be confirmed by a visual inspection. The chemical purity, residual solvents, and pH should be evaluated because residual by-products and impurities in the finished product can be harmful to patients. The half-life, radiochemical purity, radionuclidic purity, and strength need to be assessed by analyzing the radiation emitted from radiopharmaceuticals to verify that the radioisotope contents are properly labeled on pharmaceuticals. Radiopharmaceuticals always carry the risk of radiation exposure. Therefore, the time taken for quality control tests should be minimized and care should be taken to prevent radiation exposure during handling. This review discusses the quality control procedures and acceptance criteria for a diagnostic radiopharmaceutical.
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6. Others (기타) > Others (기타) > 1. Journal Papers
Yonsei Authors
Park, Jun Young(박준영) ORCID logo https://orcid.org/0000-0003-3403-2767
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