FDA质量风险管理规程

1、药业有限公司 Gosun Pharmaceutical Co., Ltd.标 题：药品质量风险管理规程Title:Quality Risk Management Procedure版 本： 第一版Version： 页 号： Page：编 号Document number：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 quali

2、ty 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 adhere to this procedure.3.2质量风险管理组长Team leader of quality risk management3.2.1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 pro

3、cess as defined in this SOP is followed and that adequate resources are available.3.3质量受权人：负责批准质量风险评估表 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） (current )EU GMP 指南 Volume 4ICH Q9 5. 内容 Contents5.1定义Definition5.1.1可测定性：发现或测定危险源存在的

4、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

5、across the product life cycle.5.1.5可能性：有害事件发生的频率或可能性。Likelihood - frequency or probability of the adverse event occurring.5.1.6严重性：对危险源可能造成的后果的衡量Severity - A measure of the possible consequences of a hazard.5.1.7风险评估：对可能造成系统故障的原因进行仔细检查，以便做出合理可行的决策，减少或者预防故障的发生。Risk Assessment - A careful examination of what could cause failure of the system so that decisions can be made about what is reasonably practicable to reduce or prevent malfunctions.5.2质量风险管理程序的适用范围包括并不局限于以下情况：This quality risk management

6、procedure applies but not limited to the following issues:5.2.1确定洁净房间和洁净空气设施的监控位置。Defining environmental monitoring positions of clean room and HVAC systems;5.2.2设定生产的标准和工艺参数。Establishing limits and parameters of manufacturing process;5.2.3评估变更影响。Evaluating effect of changes;5.2.4确定偏差调查和纠正措施的程度。Determining levels of deviation investigations and correction actions;5.2.5评估工艺的薄弱和高风险区。Evaluating and defining weakness and high-risk issues of manufacturing process.5.3质量风险管理流程Quality Risk Management Pr

7、ocess 5.4启动质量风险管理程序Initiating a Quality Risk Management Process.5.4.1执行以下步骤，启动并计划质量风险管理程序。A quality risk management process is planned and initiated as follows: 5.4.1.2确定风险项目 Define the risk question确定难题或风险问题，包括对相关潜在风险的设想。质量风险评估从一个定义明确的难题或风险疑问开始。Define the problem and/or risk question, including pertinent assumptions identifying the potential for risk. Quality risk assessments begin with a well-defined problem description or risk question.5.4.1.3组建质量风险管理小组 Organize a quality risk management team

8、 由难题或风险问题部门负责人或其指定的人员担任组长，风险管理小组的成员应该至少包括该难题或风险问题部门的成员及QA人员。同时根据需要，也可以邀请其他相关部门的专业成员参加。The person in charge of or the person designated by the person in charge of the department which possesses the problem or risk question is designated as the leader of quality risk management team, and personnel engaged in the department which possesses the problem or risk question QA personnel should be involved in the quality risk management team at least. Experts of other relevant department might be involved

9、 in the team, where necessary. 5.4.1.4风险管理小组组长，搜集潜在危险源、危害或风险评估相关的人员健康影响的背景资料或数据，并向风险管理小组的成员讲解整个项目的情况，帮助风险管理小组成员了解整个项目。The leader of quality risk management team assembles background information and/or data on the potential hazard, harm or human health impact relevant to the risk assessment and explains the program to team members to help them get to know this program. 5.4.1.5风险管理小组成员依据自己的专业，使用5.6中介绍的质量风险管理方法，找到该项目中可能存在的影响到产品质量的危险源，并对这些危险源进行分析讨论，确认各类危险源对最终产品质量影响的严重性，风险管理小组组长根据最后的风险分析的结果，起草质量风险评估表（编号：G04.016- R1）第一部分内容，质量风险评估表第一部分的内容应包括但不限于：风险项目名称、存在的危险源、风险发生后的危害、目前的控制方式等。According to their expertise, quality risk management team me

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