1.1 本指南将连续工艺验证描述为工艺验证的替代方法，其中制造工艺（或支持公用设施系统）的性能被持续监控、评估和调整（根据需要）。这是一种基于科学的方法，用于验证流程能够并将持续生产满足其预定关键质量属性的产品。连续工艺验证（ICH Q8）类似地描述为连续质量验证。 1.2 制药和生物制药产品制造公司需要提供保证，确保用于制造受管制产品的工艺生产的产品具有与产品安全性和有效性相关的规格、同一性和纯度等特定关键质量属性。过程验证是公司提供这种保证的一种方式。 1.3 利用在产品生命周期中获得的知识，将建立持续质量改进的框架，在可能的情况下: (1) 风险识别， (2) 风险减轻， (3) 工艺变异性降低， (4) 工艺能力增强， (5) 定义或增强流程设计空间，并最终 (6) 产品质量提高。这可以实现许多好处，同时解决合规性和运营目标（例如，实时发布、持续的流程改进）。 1.4 本指南中的原理可应用于药品或活性药物成分/原料药制药和生物制药分批或连续生产工艺或支持实用系统（例如，纯化水和注射用水系统的TOC等）。1.5 本指南中的原则可应用于新工艺或产品的开发和制造，或用于现有工艺的改进或重新设计，或两者兼而有之。 1.6 连续过程验证可以应用于使用实时提供过程数据的频繁和客观测量的监控系统的制造过程。这些过程可以或可以不采用监测、测量、分析和控制过程性能的在线、在线或在线分析仪/控制器。相关联的过程可以具有或可以不具有设计空间。 1.7 本指南可以独立使用，也可以与ASTM International发布的其他建议的E55标准结合使用。 1.8 本国际标准是根据世界贸易组织发布的《关于制定国际标准、指南和建议的原则的决定》中确立的国际公认的标准化原则制定的贸易壁垒委员会。 ======意义和用途====== 4.1 本标准指南中描述的方法的应用应用了FDA 21世纪药品cGMP倡议中引入的基于科学的概念和原则。 4 4.2 本指南支持并符合ICH Q 8-Q 11的内容以及美国FDA、欧盟委员会、药品检验合作计划和国家食品药品监督管理总局的指导原则。 8 4.3 根据FDA行业指南PAT，“通过实时质量保证，可以通过制造过程中的持续评估来确保所需的质量属性。来自生产批次的数据可用于验证流程并反映整个系统设计概念，基本上支持每个生产批次的验证。“换句话说，用于识别关键质量属性(CQA)的累积产品和工艺了解，以及控制策略，将能够控制CQA，提供显示每个批次验证所需的信心。这与传统的离散过程验证方法相反。

1.1 This guide describes Continuous Process Verification as an alternate approach to process validation where manufacturing process (or supporting utility system) performance is continuously monitored, evaluated, and adjusted (as necessary). It is a science-based approach to verify that a process is capable and will consistently produce product meeting its predetermined critical quality attributes. Continuous Process Verification (ICH Q8) is similarly described as Continuous Quality Verification. 1.2 Pharmaceutical and biopharmaceutical product manufacturing companies are required to provide assurance that the processes used to manufacture regulated products result in products with the specified critical quality attributes of strength identity and purity associated with the product safety and efficacy. Process validation is a way in which companies provide that assurance. 1.3 With the knowledge obtained during the product lifecycle, a framework for continuous quality improvements will be established where the following may be possible: (1) risk identified, (2) risk mitigated, (3) process variability reduced, (4) process capability enhanced, (5) process design space defined or enhanced, and ultimately (6) product quality improved. This can enable a number of benefits that address both compliance and operational goals (for example, real time release, continuous process improvement). 1.4 The principles in this guide may be applied to drug product or active pharmaceutical ingredient/drug substance pharmaceutical and biopharmaceutical batch or continuous manufacturing processes or supporting utility systems (for example, TOC for purified water and water for injection systems, and so forth). 1.5 The principles in this guide may be applied during the development and manufacturing of a new process or product or for the improvement or redesign, or both, of an existing process. 1.6 Continuous process verification may be applied to manufacturing processes that use monitoring systems that provide frequent and objective measurement of process data in real time. These processes may or may not employ in-, on-, or at-line analyzers/controllers that monitor, measure, analyze, and control the process performance. The associated processes may or may not have a design space. 1.7 This guide may be used independently or in conjunction with other proposed E55 standards to be published by ASTM International. 1.8 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 Application of the approach described within this standard guide applies science-based concepts and principles introduced in the FDA’s initiative on pharmaceutical CGMPs for the 21st century. 4 4.2 This guide supports, and is consistent with, elements from ICH Q8 – Q11 and guidelines from USFDA, European Commission, Pharmaceutical Inspection Co-operation Scheme, and the China Food and Drug Administration. 8 4.3 According to FDA Guidance for Industry, PAT, “With real time quality assurance, the desired quality attributes are ensured through continuous assessment during manufacture. Data from production batches can serve to validate the process and reflect the total system design concept, essentially supporting validation with each manufacturing batch.” In other words, the accumulated product and process understanding used to identify the Critical Quality Attributes (CQAs), together with the control strategy, will enable control of the CQAs, providing the confidence needed to show validation with each batch. This is as opposed to a traditional discrete process validation approach.