ASTM-E2500 › Historical Revision Information
Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
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Scope
1.1 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.
1.2 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 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.
1.6 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.
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, 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.
5.4 This guide may be used independently or in conjunction with other proposed E55 standards to be published by ASTM International.
Keywords
ICS Number Code 11.120.99 (Other standards related to pharmaceutics)
To find similar documents by ASTM Volume:
14.01 (Healthcare Informatics)
To find similar documents by classification:
11.120.99 (Other standards related to pharmaceutics Including equipment for pharmaceutical industry)
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Document Number
ASTM-E2500-07(2012)
Revision Level
2007 R12 EDITION
Status
Superseded
Modification Type
Reapproval
Publication Date
Nov. 1, 2012
Document Type
Guide
Page Count
5 pages
Committee Number
E55.03