ASTM E2500-13
制药和生物制药生产系统和设备的规范, 设计与验证的标准指南

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

被代替

标准号

ASTM E2500-13

发布

2013年

发布单位

美国材料与试验协会

替代标准

ASTM E2500-20

当前最新

ASTM E2500-20

 

 

引用标准

ASTM E2363 ASTM E2474 ASTM E2475 ASTM E2476 ASTM E2537 ASTM E2629

适用范围

5.1x00a0;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, and to satisfy requirements for design, installation, operation, and performance.

5.2x00a0;The approach described in this guide applies concepts and principles introduced in the FDA initiative, Pharmaceutical cGMPs for the 21st Centuryx2014;A Risk-Based Approach.

5.3x00a0;This guide supports, and is consistent with, the framework described in ICH Q8, ICH Q9, ICH Q10, and ICH Q11.

5.4x00a0;This guide may be used independently or in conjunction with other E55 standards published by ASTM International.

1.1x00a0;This guide is applicable to all elements of pharmaceutical and biopharmaceutical manufacturing systems including: 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.

1.2x00a0;For brevity, these are referred to throughout the rest of this guide as manufacturing systems.

1.3x00a0;This guide may also be applied to laboratory, information, and medical device manufacturing systems.

1.4x00a0;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.

1.5x00a0;This guide is applicable throughout the life-cycle of the manufacturing system from concept to retirement.

1.6x00a0;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.

ASTM E2500-13相似标准

推荐

谁引用了ASTM E2500-13 更多引用