藥品质量风险评估管理规程.docVIP

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. 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 available. 3.3质量受权人：负责批准《质量风险》及关闭风险管理程序。 The Qualified Person: approve 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、信息交流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 during the life circle of products. 4. 引用标准及文件 References 《药品生产质量管理规范（现行版）》 EU GMP 指南 Volume 4 EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use（Volume 4） ICH Q9 5. 内容 Contents 5.1定义Definition 5.1.1可测定性：发现或测定危险源存在的能力 Detectability - the ability to discover or determine the existence, presence, or fact of a hazard. 5.1.2危害：对健康的伤害，包括产品质量缺陷或可获得性造成的伤害 Harm - damage to health, including the damage that can occur from loss of product quality or availability. 5.1.3危险源：潜在的危害来源。 Hazard - the potential source of harm. 5.1.4质量风险管理：一套系统的程序，用于药物产品生命周期中的风险评估、控制、信息交流以及回顾。 Quality risk management - a systematic process for the assessment, control, communication and review of risks to the quality of the drug (medicinal) product across the p