全自动血凝仪的确认与验证实验研究

Qualification and Validation Study of Automatic Coagulation Analyzer

目的:按照《药品生产质量管理规范》(GMP)及数据可靠性检查的要求,对质控实验室的全自动血凝仪进行确认与验证实验研究。方法:对全自动血凝仪按照GMP要求进行安装确认(IQ)、运行确认(OQ)和性能确认(PQ)实验。结果:IQ完成了设备信息核查并记录;OQ准确度确认、精密度确认、干扰实验测试确认均符合要求;PQ采用人凝血因子VIII产品测定效价,测定值在规定的合格范围内,且CV值(2.05%)符合规定。结论:该STAGO全自动血凝仪成功实施了全面的检验仪器确认与验证,符合人凝血因子效价测定实验的要求。

Objective To carry out qualification and validation study of automatic coagulation analyzeraccording to the requirements of GMP and Data Integrity. Methods： Installation qualification （IQ）, operationalqualification （OQ）, as well as performance qualification （PQ） for STAGO coagulation analyzer were carried outaccording to the requirement of GMP. Results： IQ implemented a comprehensive verification of the equipmentand made a record; OQ accuracy confirmation, precision confirmation and interference testing confirmation all metthe requirements. PQ was determined using the human coagulation factor VIII product to test the valence and themeasured value was within the specified range and the CV value （2.05%） was in accordance with the regulations.Conclusion： The comprehensive qualification and validation of automatic STAGO coagulation analyzer weresuccessfully implemented. The instrument met the requirements of human coagulation factor potency assay.