q9質量風險管理中英文對照(編輯修改稿)

　

【文章內容簡介】 ensurate with the level of risk. 質量風險管理的兩條基 本原理是： 1. 評估質量風險應基于科學知識并最終同對病人的保護聯系起來。 2. 投入的努力程度、管理的正式程度及文件管理水平應與風險水平相適應。 4. GENERAL QUALITY RISK MANAGEMENT PROCESS 4. 質量風險管理基本過程 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. 質量風險管理是對藥品質量風險進行評估，控制，交流和審查的系統過程，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，各因素受關注程度會因風險的特異而各有區別 。 Contains Nonbinding Remendations Figure 1:典型質量風險管理過程簡介 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，這些信息可用于調整風險模型；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要求，也表示風險管理過程需要重頭再來。 啟動質量風險管理 風險鑒定 風險分析 風險評估 風險評估 風險質量管理的效果 /結果 風險降低 風險接受 風險控制 事件審核 風險交流 風險管理工具 不合格 Contains Nonbinding Remendations Responsibilities . 職責分配 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. 質量風險管理經常是但也不總是由交叉學科團隊執行 。除了要有風險管理方面的經驗人士，團隊還應包括相關領域的專家（ 例如：質量小組、事業發展、工程、管理，生產、行銷、法律、統計和臨床方面等。決策者必須負責組織協調各部門之間的關系，保障團隊各項功能的有效發揮，確保整個管理過程得以合理展開、不斷完善、反復審查，保障有足夠的資源供團隊使 用。 Initiating a Quality Risk Management Process 質量風險管理的啟動 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。 質量風險管理應包括這樣一些系統程序，這些設計好的程序用來協調，推動和改善那些風險方面基于科學認識的決定。一項管理程序的發起和設計可能要經過如下步驟： ?定義存在的難題和風險問題，包括識別潛在風險的相關假設； ?收集風險評估相關的關于潛在危險、危害或人體健康影響的背景信息和數據； ?確定領導人和重要資源； ?詳細說明決策的時間表，可交付性和適當的標準。 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