【正文】 ? Preliminary Hazard Analysis (PHA)。一旦一個(gè)質(zhì)量風(fēng)險(xiǎn)管理過(guò)程開(kāi)始啟動(dòng)，它便用于管理那些可能會(huì)影響最初質(zhì)量風(fēng)險(xiǎn)管理決策的事件，不管這些事件是計(jì)劃中的（產(chǎn)品回顧結(jié)果，自檢、審計(jì)和變更控制管理）還是計(jì)劃外的（如失敗調(diào)查的根由，召回）。 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。風(fēng)險(xiǎn)控制過(guò)程中以下問(wèn)題會(huì)受到關(guān)注：風(fēng)險(xiǎn)水平是否高于可接受水平之上？怎樣做才能降低乃至消除風(fēng)險(xiǎn)？如何尋求效益、風(fēng)險(xiǎn)和資源之間的合適平衡？對(duì)已確定風(fēng)險(xiǎn)進(jìn)行控制時(shí)是否會(huì)引入新的風(fēng)險(xiǎn)？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(xiǎn)抑低：此過(guò)程著力于減輕或避免超過(guò)一定水平（可接受水平）的質(zhì)量風(fēng)險(xiǎn)，包括為減輕危害嚴(yán)重性和發(fā)生可能性而采取的一系列措施，還包括一些致力于改善危險(xiǎn)及質(zhì)量風(fēng)險(xiǎn)可檢測(cè)性的程序。評(píng)估結(jié)果可以是對(duì)風(fēng)險(xiǎn)的定量表示，也可以是對(duì)分險(xiǎn)程度的定性描述。這一過(guò)程為后續(xù)步驟奠定了基礎(chǔ)。 ? Specify a timeline, deliverables and appropriate level of decision making for the risk management process. 質(zhì)量風(fēng)險(xiǎn)管理應(yīng)包括這樣一些系統(tǒng)程序，這些設(shè)計(jì)好的程序用來(lái)協(xié)調(diào)，推動(dòng)和改善那些風(fēng)險(xiǎn)方面基于科學(xué)認(rèn)識(shí)的決定。注解：圖中的“不可接受”項(xiàng)不僅指違背了法令法規(guī)要求，也表示風(fēng)險(xiǎn)管理過(guò)程需要重頭再來(lái)。3. PRINCIPLES OF QUALITY RISK MANAGEMENT Two primary principles of quality risk management are: ? The evaluation of the risk to quality should be based on scientific knowledge and ultimately link to the protection of the patient。有效進(jìn)行質(zhì)量風(fēng)險(xiǎn)管理能促使產(chǎn)生更好更正式?jīng)Q策，增強(qiáng)監(jiān)控者對(duì)公司處理潛在風(fēng)險(xiǎn)能力的信心，積極影響直接監(jiān)理的程度和水平。It is monly understood that risk is defined as the bination of the probability of occurrence of harm and the severity of that harm. However, achieving a shared understanding of the application of risk management among diverse stakeholders is difficult because each stakeholder might perceive different potential harms, place a different probability on each harm occurring and attribute different severities to each harm. In relation to pharmaceuticals, although there are a variety of stakeholders, including patients and medical practitioners as well as government and industry, the protection of the patient by managing the risk to quality should be considered of prime importance. 根據(jù)常規(guī)理解，風(fēng)險(xiǎn)被定義為傷害發(fā)生的可能性及嚴(yán)重程度。然而，要在不同利益集團(tuán)之間尋求風(fēng)險(xiǎn)管理應(yīng)用方面的共同認(rèn)識(shí)是相當(dāng)困難的，因?yàn)樗麄冋J(rèn)識(shí)到的潛在危害、各危害發(fā)生的可能性及嚴(yán)重程度都不同。The purpose of this document is to offer a systematic approach to quality risk management. It serves as a foundation or resource document that is independent of, yet supports, other ICH Quality documents and plements existing quality practices, requirements, standards, and guidelines within the pharmaceutical industry and regulatory environment. It specifically provides guidance on the principles and some of the tools of quality risk management that can enable more effective and consistent risk based decisions, both by regulators and industry, regarding the quality of drug substances and drug (medicinal) products across the product lifecycle. It is not intended to create any new expectations beyond the current regulatory requirements. 此文件的目的是提供質(zhì)量風(fēng)險(xiǎn)管理方面的系統(tǒng)方法。 and ? The level of effort, formality and documentation of the quality risk management process should be mensurate with the level of risk. 質(zhì)量風(fēng)險(xiǎn)管理的兩條基本原理是：1. 評(píng)估質(zhì)量風(fēng)險(xiǎn)應(yīng)基于科學(xué)知識(shí)并最終同對(duì)病人的保護(hù)聯(lián)系起來(lái)。 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 organization。一項(xiàng)管理程序的發(fā)起和設(shè)計(jì)可能要經(jīng)過(guò)如下步驟：?定義存在的難題和風(fēng)險(xiǎn)問(wèn)題，包括識(shí)別潛在風(fēng)險(xiǎn)的相關(guān)假設(shè)；?收集風(fēng)險(xiǎn)評(píng)估相關(guān)的關(guān)于潛在危險(xiǎn)、危害或人體健康影響的背景信息和數(shù)據(jù)；