ASTM E2500-07 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment 1
This standard is issued under the fixed designation E 2500; the number immediately following the designation indicates the year of original adoption or, in the ca of revision. A number in parenthes indicates the year of last re-approval. A superscript epsilon (ε) indicates an editorial change since the last revision or re-approval.
制药、生物制药生产系统和设备的规范、设计、验证标准指南
这个标准出版的固定名称是E2500;名称后紧接的数字表示最初版本的年份，或修订的情况。括号中的数字表示最近一次重新批准的年份。上标(ε)表示自从最近一次修订或重新批准以来，编辑修改情况。
1. Scope范围
怎么删除微博内容1.1 This guide is applicable to all elements of pharmaceutical and biopharmaceutical manufacturing systems including: facility equipment, supporting utilities, associated process
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monitoring and control systems, and automation systems that have the potential to affect product quality and patient safety.
1.1本指南适用于制药和生物制药生产系统中，可能影响产品质量和病人安全的所有要素，其中包括：设施设备，公用支持系统，相关过程的监控和控制系统，自动化系统。
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1.2 For brevity, the are referred to throughout the rest of thin 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 ud for the implementation of changes to existing systems, and their continuous improvement during operation. 公祭
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1.5 This guide is applicable throughout the life-cycle of the manufacturing system from concept to retirement.
1.2简要的说，这是一个全国通用的有关生产系统的小指南。
1.3本指南也可以适用于实验室，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生产系统。该方法可用于实行对现有系统的变更，并实现运行过程中，对现有系统的持续改进。
1.5本指南适用于生产系统从概念到报废的整个生命周期。
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 u. It is the responsibility of the ur of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to u.
1.6该标准不涉及讨论雇员的健康和安全，环境，或其他非GXP的规定。这一标准不是讨论所有的安全问题，如果有的话，与其使用相关。本标准的使用者的职责，是建立适当的安全和卫生标准，并在使用前确定限制性规范的适用性。
2. Reference Documents
参考文献
2.1 ASTM Standards: 2
E 2363 Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry
2.2 Other Publications:
ICH Q8 Pharmaceutical Development Handbook3
ICH Q9 quality Risk Handbook3
Pharmaceutical cGMPs for the 21st Century—A Risk-Bad Approach4
地瓜菜2.1美国试验与材料协会标准（简称：ASTM标准）
E 2363制药工业过程分析技术的有关术语
2.2其它出版物
ICH Q8 药品研发手册
ICH Q9 质量风险管理手册
21世纪药品CGMP—基于风险管理方法
3. Terminology
术语
我和我的同桌3.1 Definitions—For definitions of terms ud in this guide, refer to Terminology E 2363.
定义--这个指南中使用的术语的定义，请参阅E2363术语部分。
3.1.1acceptance criteria—the criteria that a system or component must satisfy in order to be accepted by a ur or other authorized entity.
验收标准－－这个标准必须确保某一系统或组件能够被使用者或其他授权机构所接受。
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3.1.2design reviews—planned and systematic reviews of specifications, design, and design development and continuous improvement changes performed as appropriate throughout the life-cycle of the manufacturing system. Design reviews evaluate deliverables against standards and requirements, identify problems, and propo required corrective actions.
设计回顾――在整个生产系统的生命周期中，有计划、系统地对规范、设计、设计开发和持续改进情况进行适当的回顾审查。设计回顾可根据标准和要求，交付评价，找出问题，并提出必要的纠正措施。
3.1.3manufacturing systems—elements of pharmaceutical and biopharmaceutical manufacturing capability, including manufacturing systems, facility 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.
生产系统---制药和生物制药生产能力的各要素，包括生产系统，设施设备，工艺设备，公共支持系统，相关的过程监测和控制系统，自动化系统，所有这些，都有可能影响产品质
量和病人安全。
3.1.4 subject matter experts (SMEs)—individuals with specific experti and responsibility in a particular area or field (for example, quality unit, engineering, automation, development, operations, and so forth).
相关领域的专家（SMEs）----在某一特定领域或方面（例如，质量部门，工程学，自动化技术，研发，经营，等等），个人拥有的资格和特殊技能。
3.1.5 verification—a systematic approach to verify that manufacturing systems, acting singly or in combination, are fit for intended u, have been properly installed, and are operating correctly. This is an umbrella term that encompass all types of approaches to assuring systems are fit for u such as qualification, commissioning and qualification, validation, system validation or other.
验证---是一个系统的方法，用来证实生产系统、单独或联合操作，是否符合其预定用途，是否已正确安装，并正确运行。这是一个总称，它包括所有确保系统适合其用途的方法，如确认，调试和确认，验证，系统验证或其他。
1 This guide under the jurisdiction of ASTM Committee E55 on Manufacture of Pharmaceutical Products and is the direct responsibility of Subcommittee E55.03 on General Pharmaceutical Standards.
