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
Best Sellers From Health Sector
GSO 2017:2023
Gulf Standard
Personal Care and Baby Wet Wipes
GSO 2241:2023
Gulf Standard
Cosmetic Products - Body Cleaners
GSO 2063:2023
Gulf Standard
Cosmetic Products - Hair Conditioner (Balsam)
GSO 1223:2023
Gulf Standard
Cosmetic Products-Deodorants
Recently Published from Health Sector
GSO ISO 11608-6:2024
ISO 11608-6:2022
Gulf Standard
Needle-based injection systems for medical use — Requirements and test methods — Part 6: On-body delivery systems
GSO ISO 16256:2024
ISO 16256:2021
Gulf Standard
Clinical laboratory testing and in vitro diagnostic test systems — Broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against yeast fungi involved in infectious diseases
GSO ISO 80601-2-70:2024
ISO 80601-2-70:2020
Gulf Standard
Medical electrical equipment — Part 2-70: Particular requirements for the basic safety and essential performance of sleep apnoea breathing therapy equipment
GSO ISO 14708-2:2024
ISO 14708-2:2019
Gulf Standard
Implants for surgery — Active implantable medical devices — Part 2: Cardiac pacemakers