1.1 本文件为评估制药行业PAT过程中的产品质量风险提供了指导。它解决了在该行业的初级、次级和生物技术部门的药物开发和制造中实施PAT所产生的、与PAT相关的、由PAT识别的或由PAT修改的产品质量风险。它并没有取代制药公司目前进行的风险评估，而是专门针对PAT流程的评估和设计的一个额外组成部分。请参阅指南 2500欧元 以及ICH Q8。 1.2 本标准并不旨在解决与其使用相关的所有安全问题（如有）。 本标准的使用者有责任在使用前建立适当的安全、健康和环境实践，并确定监管限制的适用性。 注意，本文中的安全指的是操作和操作员安全，而不是患者安全。 1.3 本国际标准是根据世界贸易组织技术性贸易壁垒（TBT）委员会发布的《国际标准、指南和建议制定原则决定》中确立的国际公认标准化原则制定的。 =====意义和用途====== 4.1 本指南旨在为结合过程分析技术（PAT）的制药过程的开发、日常运行和持续改进中使用风险管理提供指导。应采用一致的风险方法论使用方法，以确保开发和制造团队以及监管机构（如适用）快速传递过程理解。 4.2 本指南仅涵盖与“产品质量风险”相关的风险评估方面。其他方面（如“患者风险”）应以常规方式涵盖。

1.1 This document provides guidance on the assessment of risks to product quality within and related to PAT processes in the pharmaceutical industry. It addresses those risks to product quality arising from, associated with, identified by, or modified by the implementation of PAT in pharmaceutical development and manufacturing for primary, secondary, and biotech sectors of the industry. It does not replace those assessments of risk currently undertaken by pharmaceutical companies, but is, rather, an additional component focused specifically upon the evaluation and design of PAT processes. See Guide E2500 and ICH Q8. 1.2 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. Note that safety in this context refers to operational and operator safety, not to patient safety. 1.3 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee. ====== Significance And Use ====== 4.1 This guide is intended to provide guidance regarding the use of risk management in the development, day-to-day running, and continuous improvement of pharmaceutical processes incorporating Process Analytical Technology (PAT). A consistent approach to the use of risk methodologies should be adopted to ensure rapid transfer of process understanding within the development and manufacturing teams, and to the regulators where that is appropriate. 4.2 This guidance only covers those aspects of risk assessment related to “risk to product quality.” Other aspects (such as “risk to patient”) should be covered in the conventional manner.