药品质量风险评价管理规程

标题：药品质量风险管理规程Title: Quality Risk Management Procedure 起草人Written By 编号 Document number ：审核人Reviewed By Q/GS G04. 016-11[ZG] 版本： 第一版页号：Version：01 Page ：01/19 制订部门： 质量管理部Written department: Department 批准人Approved by 生效日期：Quality Management Effective date ：年月日年月日年月日年月日年月日分发部门： QA 办、 QC 办、粉针车间、合成车间、设备办、物控办、人力资源部、行政办、研发部、销售部Distribution to: R&D, QA, QC, API Workshop, Powder for injection Workshop, Logistics, Engineering, HR, Administration、 Sales Department 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 Responsibilities 3.1 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 adhere to this procedure. 3.2 质量风险管理组长Team leader of quality risk management 3.2.1 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. 3.2.2 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 are 标题：版本：第一版页号：02/13 药品质量风险管理规程Version ：01 Page ：Title: Quality Risk Management Procedure 编号 Docume...