cGMP培训解答.ppt

SIX SYSTEM APPROACH TO GMP IN MANUFACTURINGOF SOLID DOSAGE FORM固体制剂的六大体系; 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;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 ;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;1.4 Statistical Quality Control统计质量控制 – 1920s;1.5 The Race of Quality质量的赛跑 – 1970s;In the 1980s the USA industry learned the Japanese ways of manufacturing and caught up in quality. 在八十年代，美国工业学习了日本的生产方式并且引发了质量 Motorola General Electric initiatedthe Six-Sigma Manufacturingquality system, followedby Lean-Manufacturing. 摩托罗拉及通用电气根据精益生产，发起了六西格码质量系统 Six sigma六西格码= defect of ~ 3/106 　　　　　　　　　　　　　　　　 3/106的缺陷 Lean精益 = highest value at lowest cost 以最小的成本得到最大的价值 Current quality system concepts are the baseof FDA’s Quality System Approach to CGMP. 当前的质量系统理念是FDA的CGMP质量系统的基础 ; QUALITY IS 质量是……… What the Customers　Like 　．．．消费者喜欢什么 measured by Specifications 根据规格进行测量 got by Reducing Variability of  manufacturing通过减少生产可变性得到;