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ISPE-CCPIE CHINA CONFERENCE 2010
October 26-29 2010    Beijing Prevention and Control of Clean Room
Contamination Sources
洁净室污染来源的防治
主讲：王玮
2010.10.26
2ISPE-CCPIE CHINA CONFERENCE 2010
Prevention and Control of Clean Room Contamination Sources
洁净室污染来源的防治
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Reviewing the origin of GMP to further understand the purpose of implementing GMP •
回顾GMP 的由来，深刻理解实施GMP 的目的•
Several aspects in prevention and control of clean room contamination sources •
洁净室的污染来源防治的几个方面。•
1. Requirements and methods for clean room environment control •
洁净室空间环境控制的要求和方法•
2. Sterilization process monitoring and validation •
灭菌过程的监控和验证•
3. Selection and validation of sanitizer suppliers •
消毒剂供应商的选择和验证•
4. Personnel protection and proper gowning in clean rooms •洁净室的人员防护和正确的穿衣程序
3ISPE-CCPIE CHINA CONFERENCE 2010Definition of GMP GMP 的概念
•Good Manufacturing Practices (GMP) was first implemented in the pharmaceutical industry.
•GMP 是“Good Manufacturing Practice ”的英文缩写词，最早在医药行业实施；
•GMP is now also implemented in the food, cosmetics and veterinary drug industries.
•目前食品、化妆品、兽药等行业也在推行GMP ；
•Good Manufacturing Practices for Drugs
•《药品生产质量管理规范》简称“药品GMP”。
•GMP specifies the minimum requirements on the management of drug manufacturing process and drug quality.GMP 是对药品生产和质量管理过程的最低要求。
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ISPE-CCPIE CHINA CONFERENCE 2010Origin of GMP GMP 的由来•
Disasters resulted from use of drugs in the human history caused the origination of GMP •
人类历史上药物灾难事件导致GMP 的诞生•
The disaster events resulted from the use of drugs in the human history brings the GMP into being. Twelve major disaster events resulted from the use of drugs around the world in the 20th century.•
人类社会发生的药物灾难，促成了GMP的诞生。20世纪世界范围内发生12次较大药物伤害事件。•
The book the Jungles in the US at the beginning of the 20th century revealed the poor sanitary conditions in the production of foods. The US congress established the first law on the administration of foods and drugs in the world in 1996.  It was required in the law that products must be tested before they are distributed.•
本世纪初，美国一本《从林》之书，揭露食品生产不卫生状况，美国国会1906年制定了世界上第一部食品药品管理法。要求产品必须检验才能销售。•
A poisoning event caused by sulfonamides occurred in the US in the 1930s, which resulted in 107 cases of death. The US congress modified the Food, Drug and Cosmetic Act in 1938 to require that manufacturers must ensure that their products are safe before they are put into the market.•30年代美国发生磺胺类药物中毒事件，造成107人死亡，1938年美国国会修改《食品、药品和化妆品法》，要求生产厂商在产品上市前必须是安全的。
5ISPE-CCPIE CHINA CONFERENCE 2010Origin of GMP GMP 的由来•The Thalidomide Event occurred in the 1960s in Europe and caused more than 12,000 cases of deformed babies in 17 countries.
•60年代欧洲发生反应停事件，在17个国家造成12000多例畸形婴儿。
•GMP was first drafted by 6 professors of the Temple University of the US and was issued by the FDA of the US in 1963. And its concepts and principles are still adopted today.
•GMP 最初由美国坦普尔大学6名教授编写，1963年由美国FDA 颁布实施，其理念、原则至今仍被采用。6
ISPE-CCPIE CHINA CONFERENCE 2010Thalidomide Event 反应停事件
From the launch of Thalidomide in 1956 to its withdrawal from the market in 1962, there were altogether more than 10,000 cases of phocomelia in more than 30 countries and regions in the world (including Taiwan of China). The incidence of phocomelia in each country coincided with the sales volume of Thalidomide in the same period. There were at least 6,000 such cases in Western Germany,5,500 in the UK, more than 1,000 in Japan and at least 69 in Taiwan.从1956年反应停进入市
场至1962年撤药，全世界30多个国家和地区(包括我国台湾省)共报告了"海豹胎1万余例，各个国家畸形儿的发生率与同期反应停的销售量呈正相关，如在西德就引起至少6000例畸胎，英国出生了5500个这样的畸胎，日本约1000余例，台湾省也至少有69例畸胎出生。
7ISPE-CCPIE CHINA CONFERENCE 2010Phocomelia Caused by Thalidomide
反应停导致畸形
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ISPE-CCPIE CHINA CONFERENCE 2010Famous Statements in GMP
GMP 中著名的论断
The quality of any kinds of drugs is given by production not inspection. GMP is the law on process quality control.
任何药品质量的形成是生产出来的而不是检验出来的，使设计出来的，GMP 就是进行过程质量控制的法规。
The inherent property of drugs decides that their quality must be strictly controlled.
药品本身的特殊性决定了必须对质量进行严格控制。
Because of the restriction in taking samples, we can imagine the probability in identifying one green bean out of 500 red beans even with closed eyes.
因为取样有局限性，我们可以想像在500个红豆中加一个绿豆，大家闭上眼睛将它取出的概率有多少。
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ISPE-CCPIE CHINA CONFERENCE 2010Purpose in Implementing GMP
实施GMP 的目的
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Reducing the human errors influencing the quality of drug products to the minimum •
把影响药品质量的人为差错减少到最低程度•
Preventing any contamination of drugs to ensure the drug quality •
防止一切对药品污染现象的发生以保证药品质量•
Establishing a consummate production quality management system •
建立健全完善的生产质量管理体系•
All the laws, regulations, rules and guidelines are for one goal: to control •所有法律、法规、规则和指导大纲都是为了一个目标：控制
--Your production process shall be controlled 要控制你的生产工艺--Your suppliers shall be controlled 要控制你的供应商
--Your quality shall be controlled 要控制你的质量
10ISPE-CCPIE CHINA CONFERENCE 2010Prevention and Control of Clean Room Contamination Sourcesswabbing
洁净室污染来源的防治
•
Reviewing the origin of GMP to further understand the purpose of implementing GMP •
回顾GMP 的由来，深刻理解实施GMP 的目的•
Several aspects in prevention and control of clean room contamination sources •
洁净室的污染来源防治的几个方面。•
1. Requirements and methods for clean room environment control •
洁净室空间环境控制的要求和方法•
2. Sterilization process monitoring and validation •
灭菌过程的监控和验证•
3. Selection and validation of sanitizer suppliers •
消毒剂供应商的选择和验证•
4. Personnel protection and proper gowning in clean rooms •洁净室的人员防护和正确的穿衣程序

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