【作者】 梁毅； 孙黄颖； 沈启雯；

【Author】 LIANG Yi;SUN Huang-ying;SHEN Qi-wen;China Pharmaceutical University;

【机构】 中国药科大学国际医药商学院；

【摘要】 目的:为药品生产企业OOT确认提供可行的分析工具。方法:根据药品生产企业生产、稳定性实验等所形成记录的数据,运用休哈特控制图进行OOT评估,结合统计学原理进行确认。结果与结论:根据研究结论,应用休哈特控制图对OOT进行判断与确认,原理清晰,操作简便,结论明确。在GMP其他控制活动,也可以引入这个工具,发现异常情况,并分析原因,及时采取措施应对,完善质量标准,切实提高GMP管理水平。更多还原

【Abstract】 Objective:To provide a feasible analysis tool for OOT in the pharmaceutical production enterprises.Methods:According to the data of the production and stability test of pharmaceutical production enterprises,the OOT evaluation was conducted with the Hart control chart.Results and conclusion:According to the research conclusion,used the Hart control chart to judge and confirm the OOT,the principle is clear,the operation is simple and the conclusion is clear.In other GMP control activities,we can also introduce this tool,in order to find abnormal situation,and analyze the reasons and take measures,improve the quality standards,and effectively improve the GMP management level.更多还原