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1、 Utilization of Statistical Methods For Production Monitoring Technical Report No.59 制药技术的传播者 GMP理论的践行者 2 目目 录录 1.0 INTRODUCTION 简介简介 4 1.1 PURPOSE AND SCOPE 目的和范围 . 4 2.0 GLOSSARY OF TERMS 术语表术语表 6 3.0 STATISTICAL PROCESS CONTROL TOOLS 统计学过程控制工具统计学过程控制工具 15 3.0.1 Prerequisites for Data Analysis数据分析
2、前提 . 15 3.1 RUN CHARTS运行图 22 3.2 CONTROL CHARTS: INDIVIDUALS控制图：单值 22 3.3 MOVING RANGE CONTROL CHARTS移动极差控制图 . 24 3.4 AVERAGE AND VARIABILITY CHARTS均值图和变异性图 25 3.5 HISTOGRAMS 柱状图 . 26 3.6 PROCESS CAPABILITY (CPK, PPK) 工艺能力（CPK，PPK） . 30 3.7 EXPONENTIALLY WEIGHTED MOVING AVERAGE CHARTS 指数加权移动平均控制图 34
3、 3.8 CUSUM CHARTS累积和图 . 36 3.9 EXAMPLES OF EFFICIENT MIXTURE OF THE STATISTICAL TOOLBOX 统计工具箱有效 混合使用的实例 . 38 4.0 ACCEPTANCE SAMPLING 验收抽样验收抽样 . 40 4.1 TYPICAL APPLICATIONS 典型应用 . 40 4.2 KEY TERMS关键术语 40 4.3 TYPES OF SAMPLING 抽样类型 . 41 4.4 TYPES OF ACCEPTANCE PLANS 接收方案类型. 41 4.5 PROS AND CONS 优缺点 42
4、 5.0 APPENDICES: TECHNICAL DETAILS AND EXAMPLES 附件：技术细节和实附件：技术细节和实 例例 44 5.1 RUN CHARTS 运行图 . 44 制药技术的传播者 GMP理论的践行者 3 5.2 CONTROL CHARTS: INDIVIDUALS控制图表：单值 46 5.3 MOVING RANGE CONTROL CHARTS移动极差控制图 . 52 5.4 AVERAGE AND VARIABILITY CHARTS均值图和变异性图 57 5.5 HISTOGRAMS直方图 70 5.6 CPK，PPK FOR PROCESS CAPAB
5、ILITY过程能力 CPK,PPK值 . 71 5.7 EXPONENTIALLY WEIGHTED MOVING AREA CHARTS (EWMA) 指数加权移动区域 图（EWMA） 76 5.8 CUSUM CHARTS累积和图 . 80 5.9 SAMPLING 抽样 . 86 制药技术的传播者 GMP理论的践行者 4 1.0 Introduction 简介简介 As manufacturers seek to improve the quality of their goods， statistical methods have been rediscovered as vital
6、tools for successful development and manufacturing. Industries like automotive， electronics， and consumer products grow and change partly as a result of adopting statistical methods. 随着生产商期望提高产品质量，统计方法逐渐成为开发和生产成功的重要工具。汽车、电子、消费 品行业也部分因为采用统计方法发展和改变。 The pharmaceutical and biopharmaceutical industry in
7、creasingly recognizes the importance of statistical methods to consistently create products that conform to predetermined quality characteristics. Statistical methods provide objective evidence in meeting this goal and are fundamental for understanding the process，which enables further improvement a
8、nd development. 制药和生物制药工业越来越认识到统计方法的重要性，以持续生产符合预定质量标准的产品。统计 方法为符合这一目的提供了客观证据，也是理解工艺的基础，使持续改进和开发成为可能。 Industry and regulatory bodies are working together to provide guidance and frameworks on the use of statistical methods. The International Conference on Harmonization， International Standards Organi
9、zation and European Union have provided guidance on the use of statistical methods. 工业和监管部门正在一起努力建立统计方法使用指南和框架。ICH、ISO、EU 已经有了统计方法的 指南。 In light of the increased focus on this topic， this PDA Task Force recognized the need to provide guidance to help companies identify and use statistical methods. T
10、he primary objective of this Task Force was to convey the appropriate use of statistical methods at a level most can understand. 鉴于人们对这一主题越来越重视，PDA 工作组认识到应该建立指南帮助公司识别和使用统计方法。 该工作组的基本目的是让大多数人能够适当应用统计方法。 1.1 Purpose and Scope 目的和范围目的和范围 The purpose of this document is to present relevant and easy-to-u
11、se statistical process control (SPC) methods that are applicable to the pharmaceutical/biopharmaceutical industry. Advanced statistical methods， such as multivariate models and Design of Experiment (DoE) will not be considered. An overview of acceptance sampling is also included in Section 4.0. 本文件是
12、为了提供的相关、易用的统计过程控制方法，以应用于制药/生物制药工业。 高级统计方 法，如多变量模型和试验设计（DoE）不包含在内。4.0 节对接收取样进行了概述。 1.2 Implementation to Support Decision Making 利用统计方法为决策提供支持利用统计方法为决策提供支持 Statistical methods are intended to improve the quality of decision-making. They are simply a means to a result. If the manufacturer does not fir
13、st understand why it is utilizing a statistical method， problems such as failing to detect important signals or over-detecting unimportant normal variation can occur. Caution should be exercised to first establish the question to be answered and then statistical method to aid in answering the questi
14、on. 统计方法可用于提高决策质量。它们只是达到结果的一种手段。如果生产商没有理解为何采用统计 制药技术的传播者 GMP理论的践行者 5 方法，就可能出现无法检测重要信号或过度放大微小、正常的变动。应注意首先确定需要回答的问 题，再采用统计方法帮助回答问题。 The statistical methods may be used in an ongoing program to analyze collected data. Timely evaluation of data allows the prompt detection of undesired process variation，
15、 which facilitates process understanding and may support responses to control variability. 统计方法也可用于一个持续计划中对收集的数据进行分析。及时进行数据分析能够迅速发现非预期 的工艺变动，增加对工艺的理解，并及时采取措施对变动进行控制。 To best aid the end-user， each statistical method is described in the following format: 为了更好地帮助用户，每一统计方法按以下形式论述 Description 描述 Pros an
16、d Cons 优缺点 Typical Applications 典型应用 Technical Details and Examples (see appendices)技术细节和举例（见附件） The guidance contained in this document is not intended to establish mandatory standards for using statistical methods across a products lifecycle. 本指南不用于建立产品生命周期内统计方法应用的强制标准。 制药技术的传播者 GMP理论的践行者 6 2.0 Glossary of Terms 术语表术语表 Some of the key concepts are illustrated below; additional explanation will be in subsequent sections 以下介绍了部分主要概念，进一步解释见后续章节。 Limits 限度限度 There ar
