数据统计分析在质量标准适用性评价中的应用

Application of Data Statistical Analysis in the Applicability Evaluation of Quality Standards

目的:探讨评价质量标准适用性的数据统计分析方法。方法:以麦迪霉素片为例,对其质量数据进行统计和趋势分析、过程能力分析以及统计学假设检验,结合工艺过程分析评价质量标准的适用性。结果:通过数据统计分析,发现麦迪霉素片中间产品质量标准存在不适宜问题,调查原因实施改进,持续跟踪并分析确认了修订后标准的适用性。结论:科学的数据统计分析是确认质量标准适用性的关键,对加强过程控制、提高药品质量有重要意义。

Objective:To explore the method of data statistical analysis to evaluate the applicability of quality standards.Methods:To evaluate the applicability of quality standards by statistical and trend analysis,process capability analysis and statistical hypothesis test on quality data of Midecamycin tablets,and process analysis.Results:Quality standard of the intermediate products of Midecamycin tablets was inappropriate through data statistical analysis,and the reasons were investigated,the improvement was carried out.The applicability of the revised standard was confirmed by means of continuous tracking and analyzing.Conclusion:The scientific statistical data analysis is the key to confirm the applicability of quality standards,which is of great significance to strengthen process control and improve drug quality.