ICH-Q9璐ㄩ噺椋庨櫓绠＄悊 - 鐧惧害鏂囧簱

Quality Risk Management/质量风险管理

authorities, communication concerning quality risk management decisions might be effected through existing channels as specified in regulations and guidances.

风险沟通：是在决策者和其它人员之间分享有关风险和风险管理的信息。各方之间可以在任何风险管理过程阶段进行沟通(见图 1 的点划线箭头)。质量风险管理过程的输出/结果应当进行适当的沟通和存档(见图 1 的实线箭头)。沟通有可能包括这些相关方，例如，药政与业界、业界与患者、在一个公司、业界或药政当局内部等。所包括的信息应该与质量风险的存在性、性质、形式、概率、严重性、可接受性、控制、处理、可检测性或其它有关方面。沟通不需要对每个风险接受都进行。如果在业界和药政当局之间，就可能受影响进行质量风险管理决策沟通，则这些沟通可能通过现有的规章或指南中所说明的渠道来进行。 4.6 Risk Review 风险评审

Risk management should be an ongoing part of the quality management process. A mechanism to review or monitor events should be implemented.

质量风险管理应当是质量管理过程中的一个进行部分。应当实施一个评审或对事件进行监控的机制。

The output/results of the risk management process should be reviewed to take into account new knowledge and experience. Once a quality risk management process has been initiated, that process should continue to be utilized for events that might impact the original quality risk management decision, whether these events are planned (e.g., results of product review, inspections, audits, change control) or unplanned (e.g., root cause from failure investigations, recall). The frequency of any review should be based upon the level of risk. Risk review might include reconsideration of risk acceptance decisions (section4.4).

对风险管理过程输出/结果进行评审应当考虑采用新的知识和经验。一旦开始了某个质量风险管理过程，则该过程应该一直应用于可能影响初始质量风险管理决策的事件，而不管那些事件是已被计划的(如产品评审、检查、审计、变更控制结果)或未计划的(如从失败调查的根本原因、检查、召回)。评审频率应该取决于风险水平。风险评审可能包括对风险接受决策重新考虑(4.4 节)。 5. RISK MANAGEMENT METHODOLOGY 风险管理方法学

Quality risk management supports a scientific and practical approach to decision-making. It provides documented, transparent and reproducible methods to accomplish steps of the quality risk management process based on current knowledge about assessing the probability, severity and sometimes detectability of the risk.

质量风险管理支持科学和实际方法来进行决策。在现有关于风险概率，严重性和一些事件的可检测性评估知识的基础上，其提供文件的，透明的和可重复的方法来实现质量风险管理程序的步骤。

Traditionally, risks to quality have been assessed and managed in a variety of informal ways (empirical and/ or internal procedures) based on, for example,

compilation of observations, trends and other information. Such approaches continue to provide useful information that might support topics such as handling of complaints, quality defects, deviations and allocation of resources.

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Quality Risk Management/质量风险管理

传统上，对于质量的风险的评估和管理是基于多种非正式的方式(经验的，和/或，内部程序)，例如，现象汇总、趋势和其它资料。此类方法继续提供有用的信息，这些信息可以支持诸如处理投诉、质量缺陷、偏差与资源分配。 Additionally, the pharmaceutical industry and regulators can assess and manage risk using recognized risk management tools and/ or internal procedures (e.g., standard operating procedures). Below is a non-exhaustive list of some of these tools (further details in Annex 1 and chapter 8):

此外，制药业界与药政可以使用公认的风险管理工具，和/或，内部程序(例如，标准操作程序)来评估和管理风险。以下并非是这些工具的一个详尽的列表(详细在附件 1 和第 8 章)：

? Basic risk management facilitation methods (flowcharts, check sheets etc.); 基本风险管理简易方法(流程图，核对单等)；

? Failure Mode Effects Analysis (FMEA); 故障模式效应分析(FMEA)；

? Failure Mode, Effects and Criticality Analysis (FMECA); 故障模式影响与严重性分析(FMECA)；

? Fault Tree Analysis (FTA); 故障树分析(FTA)；

? Hazard Analysis and Critical Control Points (HACCP); 危害分析关键控制点(HACCP)；

? Hazard Operability Analysis (HAZOP); 危害及可操作性分析(HAZOP)； ? Preliminary Hazard Analysis (PHA); 预先危险分析(PHA)； ? Risk ranking and filtering; 风险排行与过滤； ? Supporting statistical tools. 辅助性统计工具。

It might be appropriate to adapt these tools for use in specific areas pertaining to drug substance and drug (medicinal) product quality. Quality risk management methods and the supporting statistical tools can be used in combination (e.g., Probabilistic Risk Assessment). Combined use provides flexibility that can facilitate the application of quality risk management principles.

在原料药和药物(医疗)产品质量的特定领域运用这些工具可能是恰当的。质量风险管理方法以及辅助统计工具可以联合使用(如，概率性风险评估)。联合使用提供了灵活性，而这种灵活性可以促进质量风险管理原则的应用。

The degree of rigor and formality of quality risk management should reflect available knowledge and be commensurate with the complexity and/ or criticality of the issue to be addressed.

质量风险管理的严格程度与和形式应当反映可利用的知识和所关注问题的复杂性，和/或严重性相当。

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Quality Risk Management/质量风险管理

6. INTEGRATION OF QUALITY RISK MANAGEMENT INTO INDUSTRY AND REGULATORY OPERATIONS 质量风险管理与业界及药政运行整合 Quality risk management is a process that supports science-based and practical decisions when integrated into quality systems (see Annex II). As outlined in the introduction, appropriate use of quality risk management does not obviate industry’s obligation to comply with regulatory requirements. However, effective quality risk management can facilitate better and more informed decisions, can provide regulators with greater assurance of a company’s ability to deal with potential risks, and might affect the extent and level of direct regulatory oversight. In addition, quality risk management can facilitate better use of resources by all parties.

质量风险管理是一个过程，当将其整合到质量体系中时(见附录 II)可以支持基于科学和实践的决策。正如在简介中所简述的，恰当地运用质量风险管理并不能免除业界遵守药政的要求。然而，有效的质量风险管理可以促使做出更好和更有远见的决策，它可以为管理者提供业界更多的应对潜在风险能力的保证并且可能会影响直接监管的范围和水平。另外，质量风险管理可以促使资源能被所有部门更好地运用。

Training of both industry and regulatory personnel in quality risk management

processes provides for greater understanding of decision-making processes and builds confidence in quality risk management outcomes.

对业界以及药政人员进行质量风险管理的培训可以更好地了解决策过程，并且对质量风险管理的结果建立信心。

Quality risk management should be integrated into existing operations and

documented appropriately. Annex II provides examples of situations in which the use of the quality risk management process might provide information that could then be used in a variety of pharmaceutical operations. These examples are provided for

illustrative purposes only and should not be considered a definitive or exhaustive list. These examples are not intended to create any new expectations beyond the requirements laid out in the current regulations.

质量风险管理应该与现有的运作和相应文件系统恰当整合。附录 II 提供了一些用到质量风险管理过程状况的例子，其可对不同的药品运作提供信息。所提供的这些例子只是出于说明的目的，其不应该被认为是一个权威性的或详尽的列表。而且它们也没有试图建立任何新的超越当前管理文件中列出的要求的期望。 Examples for industry and regulatory operations (see Annex II): 业界与药政运作的例子(见附录 II)： ? Quality management. 质量管理。

Examples for industry operations and activities (see Annex II): 业界运作与活动的例子(见附录 II)： ? Development; 开发；

? Facility, equipment and utilities; 设施、设备与公共设施；

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Quality Risk Management/质量风险管理

? 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)。

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