休哈特控制图在药品生产过程检验中的应用

Zhu Fugen
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引用次数: 4

摘要

控制图,也称为休哈特控制图,用于确定制造过程是否处于统计控制状态。这篇文章说明了使用图表来评价制药工艺的可变性。根据质量参数的特点和控制要求,介绍了几种典型的参数类型,对检测结果进行了说明,并制作了控制图,以确认生产是否得到控制。协助操作员发现因特殊因素导致的工艺变化,并采取纠正措施,使产品始终符合法规规范和生产说明。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Application of Shewhart Control Charts in the Inspection of Pharmaceutical Manufacturing Process
Control charts, also known as Shewhart Control charts, are used to determine if a manufacturing process is in a state of statistical control. This article illustrates the use of charts to evaluate pharmaceutical manufacturing process variability. According to the characteristics and control requirements of quality parameters, several types of typical parameters were introduced to illustrate the detection results and create the control charts in order to confirm whether the production was under control. Expedite the operator discovering the process variation caused by special factors, and taking corrective actions so that the products consistently complied with the regulatory specifications and production instructions.
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