控制图在药品生产质量趋势分析及异常定位管理中的应用  

Application of Control Chart in Quality Trend Analysis and Abnormal Location Management of Pharmaceutical Production

作　　者：梁毅[1] 孙黄颖[1] 沈启雯 

机构地区：[1]中国药科大学国际医药商学院,南京211198

出　　处：《中国药房》2016年第10期1297-1301,共5页China Pharmacy

摘　　要：目的:介绍控制图在药品生产质量趋势分析及异常定位管理中的应用情况,以启发药品生产企业在更多质量管理环节引入控制图作为过程控制的统计分析工具。方法:以某药品生产企业为例,阐述不同应用条件下(如稳定性实验、产品质量回顾等)控制图的选择,并结合其在某产品质量特性分析及稳定性试验过程中形成的数据,运用所选定的控制图进行实际分析说明。结果与结论:当参与统计的样本量不低于25、满足质量稳态判断的最小统计量要求时,休哈特控制图(常规控制图)即可较准确地定位出存在异常的数据;而当样本量较小时,经过数据修饰后的控制图(如回归控制图)亦可经由样本数据相对准确地体现出总体的趋势以及样本中的超趋势数据。在药品生产质量管理活动中引入控制图作为统计分析工具,是有效的控制技术手段。OBJECTIVE：To introduce the application of control chart in quality trend analysis and abnormal location management of pharmaceutical production,thus encourage pharmaceutical manufacturing enterprises to more frequently use control chart as a statistical analysis tool in quality control process. METHODS：Taking a pharmaceutical manufacturing enterprise as examples,the way for selection of different kinds of control charts in different conditions（such as stability study,product quality review）was illustrated. Based on the given data of quality characteristic analysis and stability study of a certain product in this company,analysis process was demonstrated using control chart. RESULTS CONCLUSIONS：When the sample capacity for analysis is not less than 25,meeting the minimum requirement for steady state estimation,Hugh Hart control chart（conventional control chart）alone can accurately locate the abnormal data;while under the adverse circumstance of small sample capacity,the modified control chart（such as the regression control chart）is still able to equally reflect the overall trend and out of trend（OOT）ones. As a statistical analysis tool,control chart introduced into quality management activities is an effective technic way for control.

关 键 词：控制图 药品生产质量管理规范 超趋势数据 质量管理 

分 类 号：R95[医药卫生—药学]