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1、Simon Rusmin,March 17 and 18, 2006,SIX SYSTEM APPROACH TO GMP IN MANUFACTURING OF SOLID DOSAGE FORM 固体制剂的六大体系,Presented by sFDA & Alliance Pharm on 浙江省药监局& 美国洲际药业 17, 18 March 2006 Hangzhou, China Speaker Simon Rusmin, Ph.D.,Simon Rusmin,March 17 and 18, 2006,SEMINAR CONTENTS 研讨会内容 Quality System Ap
2、proach to GMP Microbes in non-sterile manufacturing Validation Principles and Practices Preparing for regulatory inspection,Simon Rusmin,March 17 and 18, 2006,QUALITY SYSTEM APPROACH TO GMP GMP的质量系统,Simon Rusmin,March 17 and 18, 2006,The FDA experts studied all quality systems including those of non
3、-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 initiated science-based & risk-base quality system approach 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
4、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,1.1 Why Quality System Approach 为什么使用质量系统法?,Simon Rusmin,March 17 and 18, 2006,Unlike adult wild animals, human beings need products (goods and services) p
5、rovided 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 characteristics of 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 manufacturing Quality 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,1.2 What is Quality什么是质量?,Simon Rusmin,March 17 and 18,
6、 2006,1.3 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 & pride make 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 controls make QUALITY 科学控制造就了质量 Low variability
7、 可变化性低,Simon Rusmin,March 17 and 18, 2006,1.4 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
8、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，出现了后来的生活 消费品潮,Simon Rusmin,March 17 and 18, 2006,1.5 The Race of Quality质量的赛跑 1970s,After
9、WWII, Deming taught Japanese industry methods and techniques of quality management & improvement. 第二次世界大战后，戴明教给了日本人工业方法和质量管理 及改进方法 Japan perfected quality into Total Quality Management日本把质量完善为总的质量管理: Top management commits to quality 主管管理质量 Everyone participate in quality 人人参与质量 Processes are contin
10、uously improved 工艺不断改进 In 1976 the USA-FDA issued Good Manufacturing Practices. 1976年美国FDA发布了质量生产规范GMP,Simon Rusmin,March 17 and 18, 2006,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 initiat
11、ed the Six-Sigma Manufacturing quality system, followed by 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 base of FDAs Quality System Approach to CGMP. 当前的质量系统理念是FDA的C
12、GMP质量系统的基础,1.6 Quality in the 21th Century 21世纪的质量,Simon Rusmin,March 17 and 18, 2006,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,1.6a QUICK SUMMARY快速总结,Simon Rusmin,March 17 and 18, 2006,1.7 What is a Pro
13、cess什么是过程?,Changing low-value INPUT into high-value OUTPUT把低价值的输入变成高价值的输出,Simon Rusmin,March 17 and 18, 2006,1.8 Knowledge is Power 知识就是力量,Process Knowledge is the power to control the process工艺知识是控制过程的力量,Alvin Toffler托夫勒 The THIRD WAVE 第三次 浪潮-1980,Simon Rusmin,March 17 and 18, 2006,1.9 Process Thre
14、e Factors过程的三个因素,Factors contribute to Process variability影响过程可变性的因素,Simon Rusmin,March 17 and 18, 2006,1.10 The Business Process Flow商业的工艺流程,Business is a change of processes the output of one process is the input of the next process商业是过程的变更 一个过程的输出是下一个过程的输入,Simon Rusmin,March 17 and 18, 2006,Produ
15、ct Development leads to Manufacturing Authorization (NDA, ANDA, DMF process/product specs) Facility, Utility, Equipment mapping, qualification and validation.产品的发展导致了生产核准（ NDA, ANDA, DMF 工艺/产品规格），设备，公共设施的系统图，确认和验证 Establish maintenance/calibration. 建立维护/校准 Process-mapping, Risk-analysis (FMEA, HACCP
16、), & establish Process-controls. 工艺描述，风险分析(FMEA, HACCP), & 建立工艺控制 Establish Material-testing and Process-monitoring, In-process, intermediate, and finished product testing. Set-up Testing-laboratories. 建立材料检验和工艺监测，内控标准，中间体和成品检验，建立测试实验室 Documentation and Knowledge-transfer to operators & managers through continuous training. 不断的对操作者&管理者进行文件建立及知识培训 Change-control & Problem-solving (Deviation, OOS, & conformance), and establish CAPA
