Abstract: It is an urgent matter to research and develop the PET radiopharmaceuticals, which is up to the national standard for clinical use keeping pace with the growth of application of PET in China. Time factor necessitates new concepts of quality control (QC) to be strength, which is the quality assurance (QA) under the regulatory control for this kind of radiopharmaceuticals, the action of the routine test for finished products is regarded as a complementary testimony of the quality.