cGMP培训.ppt

SEMINAR CONTENTS 研讨会内容 Quality System Approach to GMP  Microbes in non-sterile manufacturing  Validation Principles and Practices Preparing for regulatory inspection QUALITY SYSTEM APPROACH TO GMP GMP的质量系统 1.1 Why Quality System Approach为什么使用质量系统法? The FDA experts studied all quality systems includingthose of non-pharmaceutical. FDA认证专家研究了所有的包括非制药的质量系统 In August 2002 the USA-FDA initiatedscience-based risk-base quality systemapproach to CGMP. 2002年八月，美国FDA成立了以科学和风险为基础的CGMP质量系统 To be in compliance with USA CGMP EU GMP, we need to understand the approaches to know how to implement them. 为了达到美国CGMP 欧盟GMP要求，我们需要知道方法及如何执行。 First we need to understand the concept and science of QUALITY and the present day QUALITY SYSTEMS. 首先我们需要了解质量理念和知识及现行的质量系统 1.2 What is Quality什么是质量? Unlike adult wild animals, human beings need products (goods and services) provided by others.不同于成年的野生动物，人类需要由别人提供的产品（物品和服务） QUALITY is the characteristicsof Goods and Services that the users LIKE.质量是使用者对物品和服务喜欢的特征 In the science of manufacturingQuality is documented as measurable SPEFICIATIONS 生产质量知识已被当作可测量的规格写成了文件 1.3 History of Quality 质量的历史– 1850s Before the INDUSTRIAL REVOLUTION在工业革命以前 Product is UNIQUE(one of a kind). 产品是唯一的（一种一个） Personal skills pridemake QUALITY 人类的技能和自尊心造就了质量 High variability.可变化性高 After工业革命后 …… Product is UNIFORM 产品是统一的 Scientific controlsmake QUALITY 科学控制造就了质量 Low variability 可变化性低 1.4 Statistical Quality Control统计质量控制 – 1920s Nature is inherently non-UNIFORM. Its variability is of Normally Distribution. 本质上不再统一，其可变性有了正态分布 In 1920s Schewart pioneered the science of statistical quality controls: 在二十年代，休哈特倡导了统计质量控制 Statistical Sampling统计抽样 Statistical Process control统计工艺控制 Process Capability加工能力 Design of Experiment实验设计  World War II 二次世界大战(1945) - the PEAK of Industrial Revolution, and the subsequent flood of consumer goods afterward.工业革命的鼎盛时期，出现