药品质量风险评估管理规程

1. 目的 Objective建立质量风险管理程序，对可能影响到最终产品质量的风险因素进行确定，评估和控制，保证最终的产品质量。指导公司规避质量事故 或药害事件的发生，保护患者的切身利益。The Quality Risk Management Procedure is established to define, evaluate and control potential risks to product quality, and to help to avoid adverse quality issues or accidents so as to assure patient benefit.2.范围 Scope适用于公司质量体系内的质量风险管理。This procedure applies to quality risk management of Gosun quality system.3.责任 Responsibilities3.1 所有人员职责：按本规程执行质量风险评估，准备文件。It is the responsibility of all personnel conducting Quality Risk Assessment and preparing the documents to adh this procedure.3.2 质量风险管理组长Team leader of quality risk management负责协调跨职能和部门的质量风险管理。Take responsibility for coordinating quality risk management across various functions and departments of the organization.确保质量风险管理程序按本 SOP 规定执行，并且有充足的资源可用。Assure that the quality risk management process as defined in this SOP is followed and that adequate resources available.3.3 质量受权人：负责批准《质量风险评估表》及关闭风险管理程序。The Qualified Person: approve < Quality risk assessment sheet > and closing of a risk management process.3.4 QA 办：负责审核在产品生命周期内对其质量风险进行评估、控制、信息沟通和回顾评审的系统化过程。QA Office: review the systematic process of evaluation, control, communication and review of quality risks durii life circle of products.4.引用标准及文件 References《药品生产质量管理法律规范(现行版)》 (current )EU GMP 指南 Volume 4ICH Q95.内容 Contents5.1 定义 Definition可测定性：发现或测定危险源存在的能力Detectability...