Manufacturing and Quality Control of Positron Emitting Radiopharmaceuticals Produced by In-house Cyclotron

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  • SAJI Hideo
    Graduate School of Pharmaceutical Sciences, Kyoto University

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  • 薬剤合成品質管理
  • 医療用PET薬剤 薬剤合成品質管理
  • イリョウヨウ PET ヤクザイ ヤクザイ ゴウセイ ヒンシツ カンリ

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Abstract

In order to establish PET diagnosis as a routine clinical tool, manufacture's compliance with regulations under the Good Manufacturing Practice (GMP) principle for PET radiopharmaceuticals is necessary. For this purpose, the Sub-committee on Medical Application of Positron Emitting Radionuclides, Medical Science and Pharmaceutical Committee of Japan Radioisotopes Association has proposed “Standards for Compounds Labeled with Emitting Radionuclides Approved as Established Techniques for Medical Use”. This guideline includes the general notices, general rules for preparations, general tests for the quality control, quality of each PET agents, guideline for manufacturing environment and manufacturing process at manufacturing facilities of PET agents. Each facility should have a committee and establish an internal system to account for manufacturing compounds labeled with positron emitting radionuclides produced in the facility, and compile standards by referring to the “Established Standard Techniques of Labeling Compounds with Emitting Radionuclides for use as Radiopharmaceuticals:approved by the Subcommittee on Medical Application of Cyclotron-Produced Radionuclides(revised in 2009)”, in order to maintain the quality of radiopharmaceuticals.

Journal

  • RADIOISOTOPES

    RADIOISOTOPES 58 (3), 115-120, 2009

    Japan Radioisotope Association

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