ASTM_E2500-07_中英文对照

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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 case of revision. A number in

parentheses 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

1.1 This guide is applicable to all elements of pharmaceutical and biopharmaceutical

manufacturing systems including: facility equipment, supporting utilities, associated process

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。

1.2 For brevity, these 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 used for the implementation of changes to existing systems, and their continuous improvement

during operation.

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 use. It is the responsibility of the user of this standard to establish appropriate safety and

health practices and determine the applicability of regulatory limitations prior to use.

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-Based Approach4

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

3.1 Definitions—For definitions of terms used 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 user 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。

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 propose 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 expertise 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 use, have been properly installed, and are operating correctly.

This is an umbrella term that encompasses all types of approaches to assuring systems are fit for

use 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.

Current edition approved June 1,2007. Published August 2007.

本指南由ASTM 委员会 E55（医药产品的生产）管辖, 具体由 E55.03（一般的药品标准）小

组委员会直接负责。

当前版本 2007 年6月1日批准。2007 年8月出版。

2 For referenced ASTM standards, visit the ASTM website, www. astm. org, or contact ASTM

Customer Service at service@astm.org. for Annual Book of ASTM Standards volume information,

refer to the standard’s Document Summary page on the ASTM website.

有关 ASTM 标准，请访问ASTM 的网站，www.astm.org. 或联系ASTM 客户服务网站

service@astm.org . ASTM 标准的年刊信息，请参阅 ASTM 网站上本标准的文件摘要页。

3 Available from International Conference on Harmonisation of Technical Requirements for

Registration of Pharmaceuticals for Human Use(ICH),ICH secretariat, c/o IFPMA,15ch. Louis-

Dunant, P.O. Box 195,1211 Geneva 20,Switzerland, http://www.ich.org.

可联系人用药品注册技术要求国际协调会(ICH), 转ICH 秘书处，IEPMA,15 号。

邮政信箱Louis-Dunant 195,1211 Geneva 20，Switzerland、http://www.ich.org。

4 Available from Food and Drug Administration(FDA),5600 Fishers Ln., Rockville, MD 20857,

http://www.fda.gov.

可联系美国食品药品管理局(FDA), Fishers Ln., Rockville, MD 20857, http://www.fda.gov.

4. Summary of Guide

4.指南概述

4.1 This guide describes a risk-based and science-based approach to the specification, design, and

verification of manufacturing systems and equipment that have the potential to affect product

quality and patient safety.

本指南以风险和科学为基础的方法，对潜在可能影响产品质量和病人安全的生产系统和设

备的规范，设计和验证进行描述。

4.2 This guide describes a systematic, efficient, and effective way of ensuring that manufacturing

systems and equipment are fit for intended use, and that risk to product quality, and consequently

to patient safety, are effectively managed to the extent that these are affected by such systems and

equipment.

本指南描述了一个系统的、高效的和有效的方式，确保生产系统和设备符合预期的使用目

的，而且对关乎产品质量和随后病人安全的风限进行有效管理，受系统和设备影响的风险

都在范围内。

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ASTME2500-07StandardGuideforSpecification,Design,andVerificationofPharmaceuticalandBiopharmaceuticalManufacturingSystemsandEquipment1ThisstandardisissuedunderthefixeddesignationE2500;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision.Anumberinparenthe...

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