控制图在药品质量管理中的应用

目的控制图是一种质量管理的方法，通过对生产过程的关键质量特性值进行测定、记录、评估、监测，以判断生产过程是否处于受控状态。本文分析控制图在药品质量管理中的应用，拟帮助药品生产企业更好地将控制图应用到实际的生产过程质量控制中。方法通过文献资料研究，简介控制图相关的概念及控制图的原理，结合部分实例阐述控制图的绘制过程及其在药品质量管理过程中的应用。结果与结论通过建立控制图，对平均图或极差图中任何失控状态的信号作出反应并采取及时行动，是保障药品生产质量的安全、均一、稳定的措施。

Applying Control Chart in Pharmaceutical Quality Management

Objective Control chart is a method for quality management, which can measure, record, estimate and monitor the key quality characteristic value in the production process in order to judge whether the production process is in the controlled state or not. This paper analyses the application of control chart in drug quality management and plans to provide help for the drug manufacturing enterprises to make better use of control chart in the practical quality control in production process. Methods By document researching, this paper briefly introduces the relevant concept and theory of control chart, and expounds the process of rendering the control chart and the application in drug quality management combining with some examples. Results and Conclusion By establishing control chart, it is a safe, uniform and stable measure of protecting the drug production quality to respond to any out-of-control signal in average and range control chart （X-R control chart） and take actions in time.