| 杨敬鹏,徐晓楠.全自动血凝仪的确认与验证实验研究[J].中国药事,2017,(10):1153-1157 |
| 全自动血凝仪的确认与验证实验研究 |
| Qualification and Validation Study of Automatic Coagulation Analyzer |
| 投稿时间：2016-11-07 |
| DOI：10.16153/j.1002-7777.2017.10.010 |
| 中文关键词: 全自动血凝仪 人凝血因子 确认与验证 安装确认 运行确认 性能确认 |
| 英文关键词: automatic coagulation analyzer human coagulation factor qualification and validation installation qualification operational qualification performance qualification |
| 基金项目: |
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| 摘要点击次数: 1075 |
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| 中文摘要: |
| 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。 |
| 英文摘要: |
| Objective: To carry out qualification and validation study of automatic coagulation analyzer according to the requirements of GMP and Data Integrity. Methods: Installation qualification (IQ), operational qualification (OQ), as well as performance qualification (PQ) for STAGO coagulation analyzer were carried out according to the requirement of GMP. Results: IQ implemented a comprehensive verification of the equipment and made a record; OQ accuracy confirmation, precision confirmation and interference testing confirmation all met the requirements. PQ was determined using the human coagulation factor VⅢ product to test the valence and the measured 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 were successfully implemented. The instrument met the requirements of human coagulation factor potency assay. |
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