课件：版GM新理念及无菌药品相关技术介绍--张华.ppt

* * 联系方式 zhanghua@smda.gov.cn 电话：021后面内容直接删除就行 资料可以编辑修改使用 资料可以编辑修改使用 主要经营：网络软件设计、图文设计制作、发布广告等 公司秉着以优质的服务对待每一位客户，做到让客户满意！ 致力于数据挖掘，合同简历、论文写作、PPT设计、计划书、策划案、学习课件、各类模板等方方面面，打造全网一站式需求 Risk is defined as probability and Severity of harm and as the probability or severity increases the Risk and Harm increases. E.g . Inactivation , of Tetanus Toxin: If the probability of reversion due to poor inactivation is high; since the process has not been validated then the severity is high thus increasing risk exponentially. World Health Organization * * QRM starts with product Development, The product and Distribution. All these aspects of a product must be inspected. World Health Organization * * Specifications are one part of a total control strategy for the drug substance and drug product designed to ensure product quality and consistency. Other parts of this strategy include thorough product characterization during development, upon which specifications are based, and adherence to Good Manufacturing Practices; e.g., suitable facilities, a validated manufacturing process, validated test procedure, raw material testing, in-process testing, stability testing, etc. Specifications are one part of a total control strategy for the drug substance and drug product designed to ensure product quality and consistency. Other parts of this strategy include thorough product characterization during development, upon which specifications are based, and adherence to Good Manufacturing Practices; e.g., suitable facilities, a validated manufacturing process, validated test procedure, raw material testing, in-process testing, stability testing, etc. * * * * * * 5、新版GMP新理念介绍 开发 生产 发运 患者 好的风险管理能确保产品的高质量 识别 并 控制 潜在的质量问题 风险评估 风险控制 通过: 质量风险管理 * * 5、新版GMP新理念介绍 质量风险管理 风险管理的方法 基本风险管理简易办法（流程图，检查表等） 失败模式和影响分析（FMEA：Failure Mode Effects Analysis） 失败模式、影响及危害性分析（FMECA：Failure Mode, Effects and Criticality Analysis） 故障树形图分析（FTA：Fault Tre