GSO ASTM E2500:2021
Gulf Standard
Current Edition
·
Approved on
01 July 2021
·
Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
GSO ASTM E2500:2021 Files
English
5 Pages
Current Edition
Reference Language
GSO ASTM E2500:2021 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
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