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

Published by	Publication Date	Number of Pages
ASTM	10/01/2020	6

Category: ASTM

Description

ASTM E2500 – Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment

1.1 This guide is applicable to all elements of pharmaceutical and biopharmaceutical manufacturing systems including: good manufacturing practice (GMP) utility 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.