ASTM E2500-20

处处学韧

Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment

1. Scope

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.

小金库

这四啥

处处学韧

小金库 发表于 2022-8-4 16:12
这四啥

ASTM 出版的E2500指南，第一章部分

猫咪特工

谢谢分享

余默

谢谢分享

Simon-阿川

虽然看不懂，但为了一个金币，还是说一段废话吧

xqliu

制药和生物制药制造系统和设备的规范，设计和验证的标准指南
1. 范围
1.1本指南适用于制药和生物制药生产系统的所有要素，包括:GMP实用设备、工艺设备、配套设备、相关工艺监控系统和自动化系统，这些系统可能会影响产品质量和患者安全。
1.2为简单起见，这些在本指南的其余部分被称为制造系统。
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。该方法可用于实现对现有系统的更改。
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规定。本标准并不能解决所有与使用相关的安全问题。本标准的使用者有责任在使用前建立适当的安全、健康和环境做法，并确定法规限制的适用性。
1.7本国际标准是根据世界贸易组织技术贸易壁垒(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。