【正文】 n recognized in the pharmaceutical industry and it is being evident that quality risk management is a valuable ponent of an effective quality system. 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. 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 質量風險管理 的原理和實例，可用于制藥質量的不同方面。 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、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）。 3. PRINCIPLES OF QUALITY RISK MANAGEMENT 質量風險管理的原理 Two primary principles of quality risk management are: 質量風險管理的兩個首要原理是 ? The evaluation of the risk to quality should be based on scientific knowledge and ultimately link to the protection of the patient。 and 質量風險評估應以科學知識為基礎，并最終聯系到病人的保護上；以及 ? The level of effort, formality and documentation of the quality risk management process should be mensurate with the level of risk. 質量風險管理過程的努力、形式和文件程度應與風險級別相當。 4. GENERAL QUALITY RISK MANAGEMENT PROCESS 一般質量風險管理過程 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 管理是藥品在整個產品周期內質量風險的評估、控制、溝通和檢查的一個系統(tǒng)過程。 質量風險管理的一個模型見圖 1。也可使用其它模型。 框架各個組成部分的強調點可能有所不同，但是健全的過程都會詳細考慮到與某個風險相當的所有要素。 Figure 1: Overview of a typical quality risk management process圖 1：典型質量風險管理過程概要 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. 決定節(jié)點在上圖沒有說明，因為決定可發(fā)生在過程的任何一點。 這些決定可以回到前一個步驟并尋找進一步的信息、調整風險模型或者甚至根據支持這個決定的信息終止風險管理過程。 注意 : 流程圖中“不合格”不僅指法規(guī)要求，還包括重復風險評估過程的需要。 Responsibilities 職責 Quality risk management activities are usually, but not always, undertaken by inte