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卫生部近日印发《单采血浆站质量管理规范》,该规范是单采血浆站原料血浆采集管理的基本准则,适用于单采血浆站采集原料血浆的全过程。该规范白颁布之日起实施,颁布前已取得单采血浆站执业许可证的,应在2007年6月30日前达到《规范》的要求。《规范》对单采血浆站机构与人员、房屋与设施、仪器与设备、物料、卫生、文件和记录、供血浆者管理、实验室质量管理、血浆采集与储存管理、质量管理、原料血浆运输与追溯、投诉与不良反应报告、自检等做出详细规定。规范强
The Ministry of Health recently issued the “Quality Management Specification for Monogas Plasma Stations”, which is the basic guideline for plasma collection and management of raw material plasma at a single plasma collection station. It is suitable for the whole process of collecting raw plasma in a single plasma collection station. The standard white promulgated on the date of implementation, promulgated before the plasma pitting station has obtained a license, it should be June 30, 2007 to achieve “norms” requirements. The norms of the plasma apheresis institutions and personnel, housing and facilities, equipment and equipment, materials, health, documentation and records for plasma management, laboratory quality management, plasma collection and storage management, quality management, raw material plasma transport With retrospective, complaints and adverse reaction reports, self-examination and other detailed provisions. Strong norms