【文章內(nèi)容簡介】 ensurate with the level of risk. 質(zhì)量風(fēng)險管理的兩條基 本原理是： 1. 評估質(zhì)量風(fēng)險應(yīng)基于科學(xué)知識并最終同對病人的保護聯(lián)系起來。 2. 投入的努力程度、管理的正式程度及文件管理水平應(yīng)與風(fēng)險水平相適應(yīng)。 4. GENERAL QUALITY RISK MANAGEMENT PROCESS 4. 質(zhì)量風(fēng)險管理基本過程 Quality risk management is a systematic process for the assessment, control, munication and review of risks to the quality of the drug (medicinal) product across the product lifecycle. A model for quality risk management is outlined in the diagram (Figure 1). Other models could be used. The emphasis on each ponent of the framework might differ from case to case but a robust process will incorporate consideration of all the elements at a level of detail that is mensurate with the specific risk. 質(zhì)量風(fēng)險管理是對藥品質(zhì)量風(fēng)險進行評估，控制，交流和審查的系統(tǒng)過程，這一過程貫穿藥品整個生命周期。 圖 1給出了這方面的一個模型，其他模型也有應(yīng)用。具體情況不同，框架中各組分受重視水平會各有差別，可是一個有效的管理過程會將所有因素納入考慮，各因素受關(guān)注程度會因風(fēng)險的特異而各有區(qū)別 。 Contains Nonbinding Remendations Figure 1:典型質(zhì)量風(fēng)險管理過程簡介 Contains Nonbinding Remendations Decision nodes are not shown in the diagram above because decisions can occur at any point in the process. These decisions might be to return to the previous step and seek further information, to adjust the risk models or even to terminate the risk management process based upon information that supports such a decision. Note: “unacceptable” in the flowchart does not only refer to statutory, legislative or regulatory requirements, but also to the need to revisit the risk assessment process. 由于決策行為隨時都可能發(fā)生，上圖就沒有顯示決策點。這些決策有可能被反饋到上一步以尋求更多信息，這些信息可用于調(diào)整風(fēng)險模型；也可能用于管理過程的終止。注解 ：圖中的“不可接受”項不僅指違背了法令法規(guī)要求，也表示風(fēng)險管理過程需要重頭再來。 啟動質(zhì)量風(fēng)險管理 風(fēng)險鑒定 風(fēng)險分析 風(fēng)險評估 風(fēng)險評估 風(fēng)險質(zhì)量管理的效果 /結(jié)果 風(fēng)險降低 風(fēng)險接受 風(fēng)險控制 事件審核 風(fēng)險交流 風(fēng)險管理工具 不合格 Contains Nonbinding Remendations Responsibilities . 職責(zé)分配 Quality risk management activities are usually, but not always, undertaken by interdisciplinary teams. When teams are formed, they should include experts from the appropriate areas (., quality unit, business development, engineering, regulatory affairs, production operations, sales and marketing, legal, statistics and clinical) in addition to individuals who are knowledgeable about the quality risk management process. Decision makers should ? take responsibility for coordinating quality risk management across various functions and departments of their anization。 and ? assure that a quality risk management process is defined, deployed and reviewed and that adequate resources are available. 質(zhì)量風(fēng)險管理經(jīng)常是但也不總是由交叉學(xué)科團隊執(zhí)行 。除了要有風(fēng)險管理方面的經(jīng)驗人士，團隊還應(yīng)包括相關(guān)領(lǐng)域的專家（ 例如：質(zhì)量小組、事業(yè)發(fā)展、工程、管理，生產(chǎn)、行銷、法律、統(tǒng)計和臨床方面等。決策者必須負責(zé)組織協(xié)調(diào)各部門之間的關(guān)系，保障團隊各項功能的有效發(fā)揮，確保整個管理過程得以合理展開、不斷完善、反復(fù)審查，保障有足夠的資源供團隊使 用。 Initiating a Quality Risk Management Process 質(zhì)量風(fēng)險管理的啟動 Quality risk management should include systematic processes designed to coordinate, facilitate and improve sciencebased decision making with respect to risk. Possible steps used to initiate and plan a quality risk management process might include the following: ? Define the problem and/or risk question, including pertinent assumptions identifying the potential for risk。 ? Assemble background information and/ or data on the potential hazard, harm or human health impact relevant to the risk assessment。 質(zhì)量風(fēng)險管理應(yīng)包括這樣一些系統(tǒng)程序，這些設(shè)計好的程序用來協(xié)調(diào)，推動和改善那些風(fēng)險方面基于科學(xué)認(rèn)識的決定。一項管理程序的發(fā)起和設(shè)計可能要經(jīng)過如下步驟： ?定義存在的難題和風(fēng)險問題，包括識別潛在風(fēng)險的相關(guān)假設(shè)； ?收集風(fēng)險評估相關(guān)的關(guān)于潛在危險、危害或人體健康影響的背景信息和數(shù)據(jù)； ?確定領(lǐng)導(dǎo)人和重要資源； ?詳細說明決策的時間表，可交付性和適當(dāng)?shù)臉?biāo)準(zhǔn)。 Contains Nonbinding Remendations ? Identify a leader and necessary resources。 ? Specify a timeline, deliverables and appropriate level of decision making for the risk management process. Risk Assessment 風(fēng)險評估 Risk assessment consists of the identification of hazards and the analysis and evaluation of risks associated with exposure to those hazards (as defined below). Quality risk assessments begin with a welldefined problem description or risk question. When the