1.1 本指南适用于制药和生物制药制造系统的所有要素，包括:良好生产规范公用设施设备、工艺设备、辅助公用设施、相关工艺监测和控制系统以及可能影响产品质量和患者安全的自动化系统。 1.2 为简洁起见，本指南其余部分将其称为 制造系统 . 1.3 本指南也适用于实验室、信息和医疗设备制造系统。 1.4 本指南适用于新的和现有的制造系统。该方法可用于对现有系统进行更改。 1.5 本指南适用于制造系统从概念到退役的整个生命周期。 1.6 本标准不涉及员工健康和安全、环境或其他非GxP法规。本标准并非旨在解决与其使用相关的所有安全问题（如有）。 本标准的用户有责任在使用前制定适当的安全、健康和环境实践，并确定监管限制的适用性。 1.7 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》中确立的国际公认标准化原则制定的。 ====意义和用途====== 5.1 本指南中所述方法的应用旨在满足国际监管期望，以确保制造系统和设备适合预期用途，例如合格，并满足设计、安装、操作和性能要求。 5.2 本指南中描述的方法适用于FDA倡议中介绍的概念和原则， 面向21世纪的制药cGMP——一种风险- 基于 . 5.3 本指南支持并符合ICH Q8、ICH Q9、ICH Q10和ICH Q11中描述的框架。 5.4 本指南旨在符合FDA、EU和其他有关设备和设施适用性和认证的国际法规。 5.5 本指南可以单独使用，也可以与ASTM国际发布的其他委员会E55标准一起使用。

1.1 This guide is applicable to all elements of pharmaceutical and biopharmaceutical manufacturing systems including: good manufacturing practice (GMP) utility equipment, process equipment, supporting utilities, associated process monitoring and control systems, and automation systems that have the potential to affect product quality and patient safety. 1.2 For brevity, these are referred to throughout the rest of this guide as manufacturing systems . 1.3 This guide may also be applied to laboratory, information, and medical device manufacturing systems. 1.4 This guide is applicable to both new and existing manufacturing systems. The approach may be used for implementation of changes to existing systems. 1.5 This guide is applicable throughout the life-cycle of the manufacturing system from concept to retirement. 1.6 This standard does not address employee health and safety, environmental, or other non-GxP regulations. 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. 1.7 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 manufacturing systems and equipment are fit for intended use, for example, qualified, and to satisfy requirements for design, 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 . 5.3 This guide supports, and is consistent with, the framework described in ICH Q8, ICH Q9, ICH Q10, and ICH Q11. 5.4 This guide is designed to conform with FDA, EU, and other international regulations regarding equipment and facility suitability for use and qualification. 5.5 This guide may be used independently or in conjunction with other Committee E55 standards published by ASTM International.