Wilkins-Cross Contamination Webinar Jan2012课件.pptVIP

What is Cross Contamination? 什么是交叉污染？ CFR 21.211.42 Subpart C – Buildings and Facilities Design and Construction Features CFR 21.211.42 C部分 –厂房设施设计和结构特征  EMA 欧洲药物管理局 EMA Status on “Dedicated Facilities”  欧洲药物管理局对“专用厂房”的规定 EMA’s Toxicological Tool 欧洲药物管理局的毒理学工具 2011 FDA Warning Letter Excerpt  2011年 FDA警告信摘录 2011 FDA Warning Letter Excerpt 2011年 FDA警告信摘录 EMA - Lessons from the Field 欧洲药物管理局 - 业界经验教训 Risk, Hazard, Exposure风险，危害，接触 What is Risk? 什么是风险？ Mechanical and Airborne Transfer 机械和空气传递 How are ADEs Used? 如何使用ADEs? OEL or ADE? 操作者接触水平或可接受每日接触量? Minimizing or controlling the exposure reduces the risk 最小化或控制接触可降低风险 Risk Analysis – Exposure Analysis 风险分析—接触分析 Mix Up 混淆 Retention/ Carryover 残留/带入 Old vs New Cleaning Limits 新旧清洁限值的对比 What is an STV? 什么是STV（安全阈值）? Comparison of Limits 限值对比 What is the effect of adding safety factors? 增加安全因素的效果？ Mechanical and Airborne Transfer 机械和空气传递 Mechanical Transfer机械传递 Airborne Transfer 空气传递 Industrial Hygiene and GMP requirements need to be balanced 需平衡工业卫生和GMP要求 Why Use ADEs (Health-Based Limits)? 为什么采用可接受日接触值ADEs(保证健康的限值)？ * Definition of Cross-Contamination: 交叉污染的定义： Contamination of a starting material, intermediate product, or finished product with another starting material or product during production. (WHO) 在生产过程中,一种起始物料、半成品或成品被另 一种起始物料或产品污染。(世界卫生组织) Note that cross-contamination is specific type of contamination 注：交叉污染是污染的一种特定类型。 (c) ... There shall be separate or defined areas or such other control systems for the firms operations as are necessary to prevent contamination or mixups during the course of the following procedures: … (c) “……公司的操作应有单独的或特定的区域，或其他 类似控制系统，以防止在下列过程中发生污染或混淆：……” “3.6 In order to minimise the risk of a serious medical hazard due to cross-contamination, dedicated and self contained facilities must be available for the production of particular medicinal products, such as highly sensitisin