Quality System Standardization And Application Of Human Peripheral Blood Lymphocyte Medium

Objective: As a reagent used in vitro diagnosis for chromosomal disorder, human peripheral blood lymphocyte medium is mature and widely used. But now there is still no national quality standard. This study was to set up an effective quality system which was under the guidance of the state's relevant regulations and met all the national standards. Through this way we could promote the product quality of human peripheral blood lymphocyte medium, meet the Measures on Medical Instrument Registration Management that promulgated by Food and Drug Administration and achieve the aim to acquire the medical instrument registration.Methods: The culture technique used in the diagnosis of chromosomal disorder was based on Academician Xia Jiahui's decades research practice, and all the standardization of quality control on human peripheral blood lymphocyte medium were in accordance with the National Medical Instrument Producer Permission and Quality System ISO 9000 applied all over the world. Took Industrialization Base of Xiangyagene Corporation as the application platform, the quality control of human peripheral blood lymphocyte medium was improved to match the application requirement of Medical Instrument Producer Permission and Medical Instrument Registration.Results:1,Quality system of human peripheral blood lymphocyte medium was standardized.2,Medical Instrument Producer Permission was issued to Xiangyagene corporation.3,The product, human peripheral blood lymphocyte medium, had been registered as a medical instrument.Conclusion: The establishment of quality system on human peripheral blood lymphocyte medium could greatly improve the quality control of products and the quality management of bio-tech corporation. The application of quality system could speed up the transformation from research results to bio-tech products, and promote the development of native market of diagnosis on chromosomal disorder reagent.