ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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ASTM E 2500 (Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment)

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. This guide is applicable throughout the life–cycle of both new and existing manufacturing systems.

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