20160107 ECA新闻：FDA对控制图的使用给出建议

20160107 ECA新闻：FDA对控制图的使用给出建议

GMP News
07/01/2016

FDA gives Advice on the Use of Control Charts

FDA对控制图的使用给出建议

In our News entitled "Statistics and Process Validation: current Findings of the FDA", we pointed out that the FDA has been observing more and more deficiencies in the area of statistics with regard to process validation. One of the "statistical methods" - also stated in FDA's Process Validation Guidance - is the use of control charts in the context of a statistical process control (SPC). A SPC can be a valuable resource, particularly in stage 3 of the process validation lifecycle (continued/ongoing process verification).

在我们题为“FDA在统计学和工艺验证方面发现的缺陷”新闻中，我们指出了FDA已经观察到越来越多的缺陷出现在工艺验证的统计学方面。“统计学方法”之一————在FDA的工艺验证指南中也曾给出-----是在统计学工艺控制中（SPC）使用控制图。一个SPC可能是有价值的来源，尤其是在第三阶段工艺验证生命周期中（持续工艺确认）。

During an event with the Product Quality Research Institute (PQRI), Dr Daniel Peng from CDER's Office of Processes and Facilities (OPF) presented his views on the use of SPC under the heading "Using Control Charts to Evaluate Process Variability". He began with the history of control charts and their fields of application. He furthermore considered the most important rules to create and manage control charts, including types of control charts, sampling and evaluation rules according to the Western Electric Rules.

在一次药品质量研究所（PQRI）会议中，CDER的工艺和设施办公室的（DPF）DANIEL PENG博士给出了他在使用SPC方面的观点，题为“使用控制图来评估工艺动性”。他从控制图的历史以及其应用领域开始讲起。进一步考虑了更为重要的规则，用于创建和管理控制图，包括控制图类型、根据西部电子规则制订的取样和评估规则。

He concluded his presentation with examples of control charts for evaluating intra and inter-batch variabilities and site performance monitoring.   

他使用了一个控制图的例子来总结其发言，用于评估批间和批内变动性，以及现场性能监测。

The slides of the presentation "Using Control Charts to Evaluate Process Variability" are very easy to read and available for free.

发言的幻灯“使用控制图来评估工艺波动”非常易读，可以免费获取。

Are you interested in SPC and control charts? On 18/19 February, the ECA organises the Education Course "Statistical Process Control - A key tool for process understanding in the process validation life cycle" in Heidelberg, Germany.

你是否对SPC和控制图感兴趣？在2月18/19日，ECA将在德国海德堡组织培训课程，题为“统计学工艺控制----工艺验证生命周期中对工艺理解的一个关键工具”。

http://zhuyujiao1972.blog.163.com/blog/static/98694727201608115557339/