【正文】 Quality: 質(zhì)量 The degree to which a set of inherent properties of a product, system or process fulfills requirements (see ICH Q6A definition specifically for quality of drug substance and drug (medicinal) products.) 產(chǎn)品、系統(tǒng)或工藝的一組固有性質(zhì)符合要求的程度（見 ICH Q6A原料藥和藥品“質(zhì)量”的定義） Quality Risk Management: 質(zhì)量風(fēng)險管理 A systematic process for the assessment, control, munication and review of risks to the quality of the drug (medicinal) product across the product lifecycle. 在整個產(chǎn)品生命周期中 ，對藥品質(zhì)量風(fēng)險進(jìn)行評估、控制、溝通和審核的。 Harm: 危害 Damage to health, including the damage that can occur from loss of product quality or availability. 對健康的危害，包括由于產(chǎn)品質(zhì)量或產(chǎn)品可用性的缺陷而導(dǎo)致的損害。 7. DEFINITIONS 定義 Decision Maker(s): 決策者 Person(s) with the petence and authority to make appropriate and timely quality risk management decisions. 具有能力與權(quán)力來作出正確及時的質(zhì)量風(fēng)險管理決定的人。 實(shí)驗(yàn)室控制和穩(wěn)定性試驗(yàn) ? Packaging and labeling. 包裝和帖簽 Examples for regulatory operations (see Annex II): 法規(guī)操作舉例（見附錄 II） ? Inspection and assessment activities. 檢查與評估活動 While regulatory decisions will continue to be taken on a regional basis, a mon 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. 繼續(xù)根據(jù)各區(qū)域進(jìn)行法規(guī)決策時， 以相同的信息為基礎(chǔ)， 質(zhì)量風(fēng)險管理原則的 共識和應(yīng)用會有助于建立相互間的信任，并在法規(guī)工作者間達(dá)成更為一致的決策。 物料管理 ? Production。 研發(fā) ? Facility, equipment and utilities。 這些例子不是為了 創(chuàng)建現(xiàn)行法規(guī)中描述的要求以外的新期望。 附錄 II舉了一些例子， 在一些情況下質(zhì)量風(fēng)險管理過程的應(yīng)用 可提供可用于各種制藥操作中的信息。 Training of both industry and regulatory personnel in quality risk management processes provides for greater understanding of decisionmaking processes and builds confidence in quality risk management outes. 對行業(yè)人員和 法規(guī)工作者進(jìn)行質(zhì)量風(fēng)險管理過程的培訓(xùn)能更好地理解決策過程，并對質(zhì)量風(fēng)險管理成果建立可信度。 但是，有效的 質(zhì)量風(fēng)險管理會推進(jìn)更多更好的精明決策，會為法規(guī)工作者在公司處理潛在風(fēng)險的能力方面提供更多的保證， 并會影響 直接法 規(guī)疏忽的范圍和層次。 6. INTEGRATION OF QUALITY RISK MANAGEMENT INTO INDUSTRY AND REGULATORY OPERATIONS 將質(zhì)量風(fēng)險管理融入到工業(yè)和法規(guī)操作中 Quality risk management is a process that supports sciencebased 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 ply with regulatory requirements. However, effective quality risk management can facilitate better and more informed decisions, can provide regulators with greater assurance of a pany’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. 融入到質(zhì)量系統(tǒng)中時， 質(zhì)量風(fēng)險管理 是一個支持科學(xué)實(shí)用決策的過程（見附件 II）。結(jié)合使用提供了靈活性，方便質(zhì)量風(fēng)險管理原則的應(yīng)用。 風(fēng)險分級與過濾 ? Supporting statistical tools. 輔助 統(tǒng)計工具 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 bination (., Probabilistic Risk Assessment). Combined use provides flexibility that can facilitate the application of quality risk management principles. 可以將這些工具用于原料藥和藥品的某些領(lǐng)域。 危險可操作性分析（ HAZOP） ? Preliminary Hazard Analysis (PHA)。 故障樹形圖分析（ FTA） ? Hazard Analysis and Critical Control Points (HACCP)。 失敗模式效果分析（ FMEA） ? Failure Mode, Effects and Criticality Analysis (FMECA)。 以下是一些工具的一個不夠詳盡的清單（更詳細(xì)的信息見附錄 1和第 8章）： ? Basic risk management facilitation methods (flowcharts, check sheets etc.)。 這種方法在 投訴、質(zhì)量缺陷和偏差的處理以及資源分配方面 繼續(xù)提供有用信息。 根據(jù)評估風(fēng)險的概率、嚴(yán)重性和（有時）可檢測性方面的現(xiàn)有知識，它為完成質(zhì)量風(fēng)險管理過程而提供了書面的、明晰的、可再現(xiàn)的方法。風(fēng)險審核可包括對風(fēng)險接受 決策的重新考慮（ ）。 一旦啟動了質(zhì)量風(fēng)險管理過程，這個過程應(yīng)繼續(xù)用于可能影響質(zhì)量風(fēng)險管理最初決定的事件，不管這些事件是計劃好的（比如產(chǎn)品審核、檢查、審計結(jié)果、變更控制）還是未經(jīng)計劃的（比如失敗調(diào)查得出的根本原因、召回）。 應(yīng)實(shí)施審核或監(jiān)控事件的機(jī)制。行業(yè)與法規(guī)部門之間，質(zhì)量風(fēng)險管理決策的溝通會通過法規(guī)和指南中說明的現(xiàn)存渠道受到影響。 包括的信息關(guān)于質(zhì)量風(fēng)險的存在、性質(zhì)、形式、概率、嚴(yán)重性、可接受程度、控制、處理、可檢測性或其它方面。 各方可在風(fēng)險管理過程的任一階段 進(jìn)行溝通（見圖 1虛線箭頭） 質(zhì)量風(fēng)險管理過程的輸出 /結(jié)果應(yīng)進(jìn)行溝通并做好記錄（見圖 1實(shí)線箭頭）。 Risk Communication 風(fēng)險溝通 Risk munication is the sharing of information about risk and risk management between the decision makers and others. Parties can municate at any stage of the risk management process (see Fig. 1: dashed arrows). The output/result of the quality risk management process should be appropriately municated and documented (see Fig. 1: solid arrows). Communications might include those among interested parties。 在這些情況下，可達(dá)成以下一致意見，說明 質(zhì)量風(fēng)險管理策略已采用且質(zhì)量風(fēng)險已降低到規(guī)定（可接受）水平。 風(fēng)險接受可以是接受剩余風(fēng)險的正式?jīng)Q定，也可以是剩余風(fēng)險未明確說明的被動決定。 因此可再次進(jìn)行風(fēng)險評估，以鑒定并評估在實(shí)施風(fēng)險降低之后任何可能 發(fā)生 的變化。 提高危險和質(zhì)量風(fēng)險的可檢測性的過程也可作為一種風(fēng)險控制策略而采用。 Risk control might focus on the following questions: 風(fēng)險控制可關(guān)注以下問題： ? Is the risk above an acceptable level? 風(fēng)險處于可接受水平之上嗎？ ? What can be done to reduce or eliminate risks? 可采取什么措施來降低或消除風(fēng)險？ ? What is the appropriate balance among benefits, risks and resources? 效益、風(fēng)險和資源之間的平衡是怎樣的？ ? Are new risks introduced as a result of the identified risks being controlled? 已鑒定的風(fēng)險 控制住以后，有沒有引入新的風(fēng)險？ Risk reduction focuses on processes for mitigation or avoidance of quality risk when it exceeds a specified (acceptable) level (see Fig. 1). Risk reduction might include actions taken to mitigate the severity and probability of harm. Processes that improve the detectability of hazards and quality risks might also be used as part of a risk control strategy. The implementation of risk reduction measures can introduce new risks into the system or increase the significance of other existing risks. Hence, it might be appropriate to revisit the risk assessment to identify and evaluate any possible change in risk after implementing a risk reduction process. 風(fēng)險降低 關(guān)注 的是當(dāng)質(zhì)量風(fēng)險超過規(guī)定（可接受）水平時減輕或避免風(fēng)險的過程（江圖 1）。 風(fēng)險控制所作的努力 應(yīng)與風(fēng)險的重要程度成正比。 Risk Control 風(fēng)險控制