【正文】 euticals, 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. The manufacturing and use of a drug (medicinal) product, including its ponents, necessarily entail some degree of risk. The risk to its quality is just one ponent of the overall risk. It is important to understand that product quality should be maintained throughout the product lifecycle such that the attributes that are important to the quality of the drug (medicinal) product remain consistent with those used in the clinical studies. An effective quality risk management approach can further ensure the high quality of the drug (medicinal) product to the patient by providing a proactive means to identify and control potential quality issues during development and manufacturing. Additionally, use of quality risk management can improve the decision making if a quality problem arises. 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 can beneficially affect the extent and level of direct regulatory oversight. 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. It is neither always appropriate nor always necessary to use a formal risk management process (using recognized tools and/ or internal procedures ., standard operating procedures). The use of informal risk management processes (using empirical tools and/ or internal procedures) can also be considered acceptable. Appropriate use of quality risk management can facilitate but does not obviateindustry’s obligation to ply with regulatory requirements and does not replace appropriate munications between industry and regulators. 2. SCOPE 范圍 This guideline provides principles and examples of tools for quality risk management that can be applied to different aspects of pharmaceutical quality. These aspects include development, manufacturing, distribution, and the inspection and submission/review processes throughout the lifecycle of drug substances, drug (medicinal) products, biological and biotechnological products (including the use of raw materials, solvents, excipients, packaging and labeling materials in drug (medicinal) products, biological and biotechnological products). 本指南 提供了 質(zhì)量風(fēng)險管理 的原理和實例，可用于制藥質(zhì)量的不同方面。 這些方面包括貫穿原料藥、藥品、生物制劑整個生命周期的研發(fā)、生產(chǎn)、銷售、檢查和遞交 /審核過程（包括藥品、生物制劑的原料、溶劑、賦形劑、包裝和貼簽材料的使用）。 and 質(zhì)量風(fēng)險評估應(yīng)以科學(xué)知識為基礎(chǔ)，并最終聯(lián)系到病人的保護上；以及 ? 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)險管理過程的努力、形式和文件程度應(yīng)與風(fēng)險級別相當。 質(zhì)量風(fēng)險管理的一個模型見圖 1。 框架各個組成部分的強調(diào)點可能有所不同，但是健全的過程都會詳細考慮到與某個風(fēng)險相當?shù)乃幸亍?這些決定可以回到前一個步驟并尋找進一步的信息、調(diào)整風(fēng)險模型或者甚至根據(jù)支持這個決定的信息終止風(fēng)險管理過程。 Responsibilities 職責(zé) 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. 質(zhì)量風(fēng)險管理通常（但不總是）由跨學(xué)科小組進行。 Decision makers should 決策者應(yīng) ? take responsibility for coordinating quality risk management across various functions and departments of their anization。 Initiating a Quality Risk Management Process 啟動質(zhì)量風(fēng)險管理過程 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: 質(zhì)量風(fēng)險管理應(yīng)包括系統(tǒng)性的過程，設(shè)計成協(xié)調(diào)、協(xié)助并改善與風(fēng)險有關(guān)的基于科學(xué)的決策。 定義問題和 /或風(fēng)險疑問，包括識別潛在風(fēng)險的中肯假設(shè) ? Assemble background information and/ or data on the potential hazard, harm or human health impact relevant to the risk assessment。 確定一個領(lǐng)導(dǎo)和必要資源 ? Specify a timeline, deliverables and appropriate level of decision making for the risk management process. 指出風(fēng)險管理過程的時間點、顯示物以及適當程度的決策。 質(zhì)量風(fēng)險管理從明確定義的問題描述或風(fēng)險疑問開始。 為幫助清楚定義風(fēng)險，通常三個基本問題是由幫助的： 1. What might go wrong? 什么可能出現(xiàn)問題？ 2. What is the likelihood (probability) it will go wrong? 出現(xiàn)問題的可能性（概率）是多少？ 3. What are the consequences (severity)? 后果是什么（嚴重性）？ Risk identification is a systematic use of information to identify hazards referring to the risk question or problem description. Information can include historical data, theoretical analysis, informed opinions, and the concerns of stakeholders. Risk identification addresses the “What might go wrong?” question, including identifying the possible consequences. This provides the basis for further steps in the quality risk management process. 風(fēng)險鑒定 是 用系統(tǒng)性的 信息來鑒定危險，涉及到風(fēng)險疑問或問題描述。 風(fēng)險鑒定針對“什么可能出現(xiàn)問題？”，包括鑒定可能后果。 Risk analysis is the estimation of the risk associated with the identified hazards. It is the qualitative or quantitative process of linking the likelihood of occ