体外诊断试剂物流质量控制

In Vitro Diagnostic Reagent Logistics Quality Control

为确保体外诊断试剂在流通环节等方面符合要求,保障临床试剂的质量,该院按照GSP、《医疗器械经营质量管理规范》《医疗器械冷链(运输、贮存)管理指南》等对医疗器械的贮存与运输环节的整体性温控进行了管理规定,规定了体外诊断试剂物流过程中的收货、验收、贮存、在库检查、发货、运输、温度监测和控制、设施设备、人员与培训、售后服务等方面的要求,适用于采用专用设施设备,使体外诊断试剂在生产、流通与使用过程中质量控制在规定范围内的物流过程。

In order to ensure the in vitro diagnostic reagents meet the requirements in the circulation and other aspects,and to ensure the quality of clinical reagents,our hospital in accordance with GSP,"Medical Device Management Quality Management Regulations","Medical Device Cold Chain(Transport,Storage)Management Guide",etc.management of the overall temperature control of the storage and transportation of medical devices is regulated,and the receipt,acceptance,storage,inspection,delivery,transportation,temperature monitoring and control,and facility equipment in the in vitro diagnostic reagent logistics process,personnel and training,after-sales service and other aspects of the requirements are specified.It is suitable for the logistics process in which the quality of the in vitro diagnostic reagents is controlled within the specified range during the production,distribution and use of special facilities and equipment.