中国药房2016，Vol.27Issue(10)：1297-1301,5.DOI:10.6039/j.issn.1001-0408.2016.10.01
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 Pharma-ceutical Production
梁毅 1孙黄颖 1沈启雯1
作者信息
- 1. 中国药科大学国际医药商学院,南京 211198
- 折叠
摘要
Abstract
OBJECTIVE:To introduce the application of control chart in quality trend analysis and abnormal location manage-ment 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 il-lustrated. 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Key words
Control chart/GMP/OOT/Quality management分类
医药卫生引用本文复制引用
梁毅,孙黄颖,沈启雯..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[J].中国药房,2016,27(10):1297-1301,5.
