发布时间 : 星期日 文章ICH-Q9质量风险管理更新完毕开始阅读7a1f14d511a6f524ccbff121dd36a32d7275c793
? Materials management; 物料管理； ? Production; 生产；
? Laboratory control and stability testing; 实验控制和稳定性试验； ? Packaging and labeling.包装与贴标签。
Examples for regulatory operations (see Annex II): 药政运作的例子(见附录 II)：
? Inspection and assessment activities. 检查活动与评估活动。
While regulatory decisions will continue to be taken on a regional basis, a common understanding and application of quality risk management principles could facilitate mutual confidence and promote more consistent decisions among regulators on the basis of the same information. This collaboration could be important in the development of policies and guidelines that integrate and support quality risk management practices.
当药政决策将会持续在某个区域基础上应用时，对质量风险管理原则的一般了解和应用可以在相同的信息基础上促进管理者之间的相互信心并且促使他们做出更一致的决策。这个合作对于整合和支持质量风险管理实践的政策和指南的开发非常重要。
7. DEFINITIONS 定义
Decision Maker(s): 决策者：
Person(s) with the competence and authority to make appropriate and timely quality risk management decisions.
有能力和权力做出恰当的并及时的质量风险决策的人。 Detectability: 可检测性：
The ability to discover or determine the existence, presence, or fact of a hazard. 发现或确定危险存在，出现或事实的能力。 Harm: 伤害：
Damage to health, including the damage that can occur from loss of product quality or availability.
对健康的损害，包括可能由于产品质量或有效性损失引起的损害。 Hazard: 危险：
The potential source of harm (ISO/IEC Guide 51). 潜在的伤害来源(ISO/IEC 指南 51)。 Product Lifecycle: 产品生命周期：
All phases in the life of the product from the initial development through marketing until the product’s discontinuation.
从最初的开发到上市，直到产品的停止这个产品生命的所有阶段。 Quality: 质量：
The degree to which a set of inherent properties of a product, system or process fulfills requirements (see ICH Q6A definition specifically for \substance and drug (medicinal) products.)
对于一个产品，系统或过程实现需求的内在性质程度(见 ICH Q6A definition specifically for “quality” of drug substance and drug (medicinal) products)。
A systematic process for the assessment, control, communication and review of risks to the quality of the drug (medicinal) product across the product lifecycle.
用于评估，控制，沟通和评审药物(医疗)产品贯穿整个产品生命周期质量风险的一个系统化过程。
Quality System: 质量体系：
The sum of all aspects of a system that implements quality policy and ensures that quality objectives are met.
实施质量方针，保证符合质量目标所有方面的总合。 Requirements: 要求：
The explicit or implicit needs or expectations of the patients or their surrogates (e.g., health care professionals, regulators and legislators). In this document, “requirements” refers not only to statutory, legislative, or regulatory requirements, but also to such needs and expectations.
明示或隐含的需求或患者或其代理的期望(例如：保健专家，药政或立法人员)。在本文件中，“要求”不仅仅指法定的，立法或药政的要求，也包括其需求或期望。 Risk: 风险：
The combination of the probability of occurrence of harm and the severity of that harm (ISO/IEC Guide 51).
伤害发生的概率以及伤害的严重性的结合(ISO/EC 指南 51)。 Risk Acceptance: 风险接受：
The decision to accept risk (ISO Guide 73). 接受风险的决定(ISO 指南 73)。 Risk Analysis: 风险分析：
The estimation of the risk associated with the identified hazards. 对风险与已经辨识的危险因素的估计。 Risk Assessment: 风险评估：
A systematic process of organizing information to support a risk decision to be made within a risk management process. It consists of the identification of hazards and the analysis and evaluation of risks associated with exposure to those hazards.
在一个风险管理过程中用于支持所做的风险决策的组织信息的系统过程。其包含对危险因素辨识，对暴露在这些危险因素相关风险的分析，评价。 Risk Communication: 风险沟通：
The sharing of information about risk and risk management between the decision maker and other stakeholders.
在决策者和其它风险涉众之间分享有关风险以及风险管理的信息。 Risk Control: 风险控制：
Actions implementing risk management decisions (ISO Guide 73). 实施风险管理决策的行动(ISO 指南 73)。 Risk Evaluation: 风险评价：
The comparison of the estimated risk to given risk criteria using a quantitative or qualitative scale to determine the significance of the risk.
用一个定性或定量尺度对已经估计风险与给定的风险标准进行比较以确定风险显著性。
Risk Identification: 风险辨识：
The systematic use of information to identify potential sources of harm (hazards) referring to the risk question or problem description.
系统地运用信息来辨识风险问题或问题描述的伤害(危险因素)潜在来源。 Risk Management: 风险管理：
The systematic application of quality management policies, procedures, and practices to the tasks of assessing, controlling, communicating and reviewing risk.
系统化应用质量管理方针，程序以及对风险评估，控制，沟通以及评审任务中的实践。
Risk Reduction: 风险降低：
Actions taken to lessen the probability of occurrence of harm and the severity of that harm.
用于减少伤害发生的概率以及伤害的严重性所采取的行动。 Risk Review: 风险评审：
Review or monitoring of output/results of the risk management process considering (if appropriate) new knowledge and experience about the risk.
考虑(如果可能)运用关于风险新的知识和经验来评审或监测风险管理过程的输出/结果。
Severity: 严重性：
A measure of the possible consequences of a hazard. 对于某个危险因素可能结果的度量。 Stakeholder: 风险涉众：
Any individual, group or organization that can affect, be affected by, or perceive itself to be affected by a risk. Decision makers might also be stakeholders. For the purposes of this guideline, the primary stakeholders are the patient, healthcare professional, regulatory authority, and industry.
任何能影响，被影响到或认识到自己会被风险所影响的个人，团体或组织。决策者也许也会是风险涉众。本指南的目的，主要的风险涉众是患者，卫生执业者，药政以及业界。 Trend: 趋势：
A statistical term referring to the direction or rate of change of a variable(s). 一个统计学术语，指一个变量变动的方向或比率。 8. REFERENCES 参考文献
ICH Q8 Pharmaceutical Development.
ISO/IEC Guide 73: 2002 - Risk Management - Vocabulary - Guidelines for use in Standards.
ISO/IEC Guide 51: 1999 - Safety Aspects - Guideline for their inclusion in standards. Process Mapping by the American Productivity & Quality Center, 2002, ISBN 1928593739.
IEC 61025 - Fault Tree Analysis (FTA).
IEC 60812 Analysis Techniques for system reliability - Procedures for failure mode and effects analysis (FMEA).
Failure Mode and Effect Analysis, FMEA from Theory to Execution, 2nd Edition 2003, D. H. Stamatis, ISBN 0873895983.
Guidelines for Failure Modes and Effects Analysis (FMEA) for Medical Devices, 2003 Dyadem Press, ISBN 0849319102.
The Basics of FMEA, Robin McDermott, Raymond J. Mikulak, Michael R. Beauregard 1996, ISBN 0527763209.
WHO Technical Report Series No 908， 2003, Annex 7 Application of Hazard Analysis and Critical Control Point (HACCP) methodology to pharmaceuticals.
IEC 61882 - Hazard Operability Analysis (HAZOP).
ISO 14971: 2000 - Application of Risk Management to Medical Devices. ISO 7870: 1993 - Control Charts.
ISO 7871: 1997 - Cumulative Sum Charts. ISO 7966: 1993 - Acceptance Control Charts. ISO 8258: 1991 - Shewhart Control Charts.
What is Total Quality Control?; The Japanese Way, Kaoru Ishikawa (Translated by David J. Liu), 1985, ISBN 0139524339.
Annex 附录 I: Risk Management Methods and Tools风险管理方法与工具
The purpose of this annex is to provide a general overview of and references for some of the primary tools that might be used in quality risk management by industry and regulators. The references are included as an aid to gain more knowledge and detail about the particular tool. This is not an exhaustive list. It is important to note that no one tool or set of tools is applicable to every situation in which a quality risk management procedure is used.
本附录的目的在于提供一些业界和药政用于质量风险管理的基本工具的概述和参考一个总体轮廓。这些参考是作为一个辅助以获得某一特定工具的更多知识和细节。其并不是一个完整的列表。重要的是知道并不是任何一个或一套工具都可以应用于每一个质量风险管理程序的具体情况。
I.1 Basic Risk Management Facilitation Methods基本风险管理简易方法
Some of the simple techniques that are commonly used to structure risk management by organizing data and facilitating decision-making are:
一些简单的技术常用来组织资料以及简单决策制构成风险管理。这些简单技术包括：
? Flowcharts; 流程图； ? Check Sheets; 核对单； ? Process Mapping; 过程图；
? Cause and Effect Diagrams (also called an Ishikawa diagram or fish bone diagram). 因果图(也称为石川图或鱼骨图)。
I.2 Failure Mode Effects Analysis 故障模式效应分析(FMEA)
FMEA (see IEC 60812) provides for an evaluation of potential failure modes for processes and their likely effect on outcomes and/or product performance. Once
failure modes are established, risk reduction can be used to eliminate, contain, reduce or control the potential failures. FMEA relies on product and process understanding. FMEA methodically breaks down the analysis of complex processes into manageable steps. It is a powerful tool for summarizing the important modes of failure, factors causing these failures and the likely effects of these failures.
故障模式效应分析(见 IEC 60812)提供了一个评价过程潜在故障模式以及在输出和/或产品性能上的可能效应。一旦建立了故障模式，可以采用风险降低可以用于消除，包容，降低或控制潜在故障。故障模式效应分析依赖于对产品与过程的了解。故障模式效应分析有系统地将复杂过程分析方法分解为易操作的几个步骤。其对于汇总故障重要模式，引起这些故障的因素以及这些故障的可能的效应，是一个强有力的工具。 Potential Areas of Use(s) 潜在应用领域
FMEA can be used to prioritize risks and monitor the effectiveness of risk control activities.
故障模式效应分析可以用来列出需优先考虑的风险并且监督风险控制活动的有效性。
FMEA can be applied to equipment and facilities and might be used to analyze a manufacturing operation and its effect on product or process. It identifies
elements/operations within the system that render it vulnerable. The output/ results of FMEA can be used as a basis for design or further analysis or to guide resource deployment.