【正文】 Quality System:。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.)對(duì)于一個(gè)產(chǎn)品，系統(tǒng)或過(guò)程實(shí)現(xiàn)需求的內(nèi)在性質(zhì)程度(見(jiàn) ICH Q6A definition specifically for “quality” of drug substance and drug (medicinal) products)。Hazard: 危險(xiǎn)：The potential source of harm (ISO/IEC Guide 51).潛在的傷害來(lái)源(ISO/IEC 指南 51)。Detectability: 可檢測(cè)性：The ability to discover or determine the existence, presence, or fact of a hazard.發(fā)現(xiàn)或確定危險(xiǎn)存在，出現(xiàn)或事實(shí)的能力。這個(gè)合作對(duì)于整合和支持質(zhì)量風(fēng)險(xiǎn)管理實(shí)踐的政策和指南的開(kāi)發(fā)非常重要。Examples for regulatory operations (see Annex II):藥政運(yùn)作的例子(見(jiàn)附錄 II)：? Inspection and assessment activities. 檢查活動(dòng)與評(píng)估活動(dòng)。 生產(chǎn)；? Laboratory control and stability testing。 設(shè)施、設(shè)備與公共設(shè)施；? Materials management。Examples for industry operations and activities (see Annex II):業(yè)界運(yùn)作與活動(dòng)的例子(見(jiàn)附錄 II)：? Development。而且它們也沒(méi)有試圖建立任何新的超越當(dāng)前管理文件中列出的要求的期望。附錄 II 提供了一些用到質(zhì)量風(fēng)險(xiǎn)管理過(guò)程狀況的例子，其可對(duì)不同的藥品運(yùn)作提供信息。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(duì)業(yè)界以及藥政人員進(jìn)行質(zhì)量風(fēng)險(xiǎn)管理的培訓(xùn)可以更好地了解決策過(guò)程，并且對(duì)質(zhì)量風(fēng)險(xiǎn)管理的結(jié)果建立信心。然而，有效的質(zhì)量風(fēng)險(xiǎn)管理可以促使做出更好和更有遠(yuǎn)見(jiàn)的決策，它可以為管理者提供業(yè)界更多的應(yīng)對(duì)潛在風(fēng)險(xiǎn)能力的保證并且可能會(huì)影響直接監(jiān)管的范圍和水平。6. INTEGRATION OF QUALITY RISK MANAGEMENT INTO INDUSTRY AND REGULATORY OPERATIONS 質(zhì)量風(fēng)險(xiǎn)管理與業(yè)界及藥政運(yùn)行整合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.質(zhì)量風(fēng)險(xiǎn)管理是一個(gè)過(guò)程，當(dāng)將其整合到質(zhì)量體系中時(shí)(見(jiàn)附錄 II)可以支持基于科學(xué)和實(shí)踐的決策。聯(lián)合使用提供了靈活性，而這種靈活性可以促進(jìn)質(zhì)量風(fēng)險(xiǎn)管理原則的應(yīng)用。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.在原料藥和藥物(醫(yī)療)產(chǎn)品質(zhì)量的特定領(lǐng)域運(yùn)用這些工具可能是恰當(dāng)?shù)摹?預(yù)先危險(xiǎn)分析(PHA)；? Risk ranking and filtering。 危害分析關(guān)鍵控制點(diǎn)(HACCP)；? Hazard Operability Analysis (HAZOP)。 故障模式影響與嚴(yán)重性分析(FMECA)；? Fault Tree Analysis (FTA)。基本風(fēng)險(xiǎn)管理簡(jiǎn)易方法(流程圖，核對(duì)單等)；? Failure Mode Effects Analysis (FMEA)。Additionally, the pharmaceutical industry and regulators can assess and manage risk using recognized risk management tools and/ or internal procedures (., standard operating procedures). Below is a nonexhaustive list of some of these tools (further details in Annex 1 and chapter 8):此外，制藥業(yè)界與藥政可以使用公認(rèn)的風(fēng)險(xiǎn)管理工具，和/或，內(nèi)部程序(例如，標(biāo)準(zhǔn)操作程序)來(lái)評(píng)估和管理風(fēng)險(xiǎn)。Traditionally, risks to quality have been assessed and managed in a variety of informal ways (empirical and/ or internal procedures) based on, for example, pilation of observations, trends and other information. Such approaches continue to provide useful information that might support topics such as handling of plaints, quality defects, deviations and allocation of resources.傳統(tǒng)上，對(duì)于質(zhì)量的風(fēng)險(xiǎn)的評(píng)估和管理是基于多種非正式的方式(經(jīng)驗(yàn)的，和/或，內(nèi)部程序)，例如，現(xiàn)象匯總、趨勢(shì)和其它資料。5. RISK MANAGEMENT METHODOLOGY 風(fēng)險(xiǎn)管理方法學(xué)Quality risk management supports a scientific and practical approach to decisionmaking. It provides documented, transparent and reproducible methods to acplish steps of the quality risk management process based on current knowledge about assessing the probability, severity and sometimes detectability of the risk.質(zhì)量風(fēng)險(xiǎn)管理支持科學(xué)和實(shí)際方法來(lái)進(jìn)行決策。評(píng)審頻率應(yīng)該取決于風(fēng)險(xiǎn)水平。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 (., results of product review, inspections, audits, change control) or unplanned (., 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 ().對(duì)風(fēng)險(xiǎn)管理過(guò)程輸出/結(jié)果進(jìn)行評(píng)審應(yīng)當(dāng)考慮采用新的知識(shí)和經(jīng)驗(yàn)。 Risk Review 風(fēng)險(xiǎn)評(píng)審Risk management should be an ongoing part of the quality management process. A mechanism to review or monitor events should be implemented. 質(zhì)量風(fēng)險(xiǎn)管理應(yīng)當(dāng)是質(zhì)量管理過(guò)程中的一個(gè)進(jìn)行部分。溝通不需要對(duì)每個(gè)風(fēng)險(xiǎn)接受都進(jìn)行。溝通有可能包括這些相關(guān)方，例如，藥政與業(yè)界、業(yè)界與患者、在一個(gè)公司、業(yè)界或藥政當(dāng)局內(nèi)部等。各方之間可以在任何風(fēng)險(xiǎn)管理過(guò)程階段進(jìn)行溝通(見(jiàn)圖 1 的點(diǎn)劃線箭頭)。 Risk Communication風(fēng)險(xiǎn)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。這些情況下，可以認(rèn)為已應(yīng)用了恰當(dāng)?shù)馁|(zhì)量風(fēng)險(xiǎn)管理策略，并且質(zhì)量風(fēng)險(xiǎn)已降低到一個(gè)特定(可接受)的水平。風(fēng)險(xiǎn)接受可以是一個(gè)接受剩余風(fēng)險(xiǎn)的正式?jīng)Q定或者是當(dāng)剩余風(fēng)險(xiǎn)不具體時(shí)的被動(dòng)接受。因此，在實(shí)施風(fēng)險(xiǎn)降低過(guò)程后，可能會(huì)適當(dāng)?shù)胤祷氐斤L(fēng)險(xiǎn)評(píng)估中對(duì)風(fēng)險(xiǎn)中任何可能的改變進(jìn)行辯識(shí)和評(píng)價(jià)。改善危險(xiǎn)因素和質(zhì)量風(fēng)險(xiǎn)可檢測(cè)性的過(guò)程也可能作為一個(gè)風(fēng)險(xiǎn)控制策略中的一個(gè)部分。Risk control might focus on the following questions:風(fēng)險(xiǎn)控制可能會(huì)集中在下列問(wèn)題：? Is the risk above an acceptable level?是否風(fēng)險(xiǎn)超過(guò)了一個(gè)可接受的水平?? What can be done to reduce or eliminate risks?什么方法可以用來(lái)降低或消除風(fēng)險(xiǎn)?? What is the appropriate balance among benefits, risks and resources?效益、風(fēng)險(xiǎn)和資源之間的恰當(dāng)?shù)钠胶恻c(diǎn)是什么?? Are new risks introduced as a result of the identified risks being controlled?控制已經(jīng)所辨識(shí)的風(fēng)險(xiǎn)是否引入新的風(fēng)險(xiǎn)?Risk reduction: focuses on processes for mitigation or avoidance of quality risk when it exceeds a