1.1 本指南旨在作为指南的补充 E2500 . 1.2 本指南适用于指南中描述的制造系统范围 E2500 ，特别是用于制造制药和生物制药产品的一次性系统的所有元件，或一次性和传统组件的混合体，包括:结构材料、组件、组件、歧管、配套设施、相关过程监测和控制系统、自动化系统和有可能影响产品质量和患者安全的受控环境。 1.3 本指南适用于对现有系统实施制造系统设计变更。它可用于从临床到商业规模的持续改进和操作变化。1.4 为简洁起见，在本指南的其余部分中，一次性系统被称为SUS。 1.5 该方法可以由最终用户、SUS的供应商和供应链中更靠后的原材料子供应商应用。 1.6 本指南不适用于包装、初级容器、组合产品（由药物、器械或生物制品的任何组合组成的产品）或器械的一次性技术的使用。 1.7 本指南不涉及特定的本地要求，这些要求仍由最终用户负责。 1.8 本指南不涉及员工健康和安全、环境或其他良好工程和制造规范(GxP)要求。本标准并不旨在解决与其使用相关的所有安全性问题（如果有）。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法规限制的适用性。 1.9 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《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。 ======意义和用途====== 5.1 本指南中描述的方法的应用旨在满足国际监管期望，确保SUS适合其预期用途，并满足采购、供应、设计、规格、安装、操作和性能的要求。5.2 本指南中描述的方法应用了FDA倡议《21世纪制药cGMP——基于风险的方法》中介绍的概念和原则。它支持并符合ICH Q7、ICH Q8(R2)、ICH Q9(R1)和ICH Q10中FDA行业工艺验证指南:一般原则和实践中描述的框架。 5.3 本指南包括PDA第66号技术报告中开发的概念。 5.4 本指南可以独立使用，也可以与ASTM国际发布的其他ASTM委员会E55建议标准结合使用。 5.5 供应商和最终用户应使用有关浸提物、沥滤物、颗粒物、完整性检测/泄漏检测、生物相容性和原材料的特定标准实践，并应用于他们自己的生产工艺设施。

1.1 This guide is intended as a complement to Guide E2500 . 1.2 This guide is applicable to the range of manufacturing systems described in Guide E2500 , specifically all elements of single-use systems, or hybrids of single-use and traditional components, used for the manufacturing of pharmaceutical and biopharmaceutical products, including: materials of construction, components, assembly, manifolds, supporting utilities, associated process monitoring and control systems, automation systems, and controlled environment that have the potential to affect product quality and patient safety. 1.3 This guide is applicable for the implementation of changes to manufacturing system design for existing systems. It may be used for continuous improvement and changes in operation from clinical through to commercial scale. 1.4 For brevity, single-use systems are referred to as SUS throughout the rest of this guide. 1.5 The approach may be applied by the end user, the supplier of SUS, and raw materials sub-suppliers further back in the supply chain. 1.6 This guide is not intended to apply to the use of single-use technology for packaging, primary containers, combination products (products composed of any combination of a drug, device, or biological product) or devices. 1.7 This guide does not address specific local requirements, which remain the responsibility of the end user. 1.8 This guide does not address employee health and safety, environmental, nor other good engineering and manufacturing practices (GxP) requirements. 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. 1.9 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 ====== 5.1 Application of the approach described within this guide is intended to satisfy international regulatory expectations in ensuring that SUS are fit for their intended use and to satisfy requirements for sourcing, supply, design, specification, installation, operation, and performance. 5.2 The approach described in this guide applies concepts and principles introduced in the FDA initiative, Pharmaceutical CGMPs for the 21st Century—A Risk-Based Approach. It supports and is consistent with the framework described in FDA Guidance for Industry—Process Validation: General Principles and Practices, in ICH Q7, ICH Q8 (R2), ICH Q9 (R1), and ICH Q10. 5.3 This guide includes concepts developed in the PDA Technical Report No. 66. 5.4 This guide may be used independently or in conjunction with other ASTM Committee E55 proposed standards to be published by ASTM International. 5.5 Specific standard practices about extractables, leachables, particulate matter, and integrity testing/leak detection, biocompatibility, and raw materials as available should be used by suppliers and end users and applied to their own manufacturing process facilities.