This recently published ASTM guide defines a risk-based and science-based approach to the specification, design and verification of pharmaceutical and biopharmaceutical manufacturing systems and equipment. It is applicable to all elements of pharmaceutical and biopharmaceutical manufacturing systems including: facility equipment, process equipment, supporting utilities, monitoring & control systems and automation systems, with the potential to affect product quality and patient safety. The guide may also be applied to laboratory, information and medical device manufacturing systems.
For brevity, these are referred to throughout the guide as ‘manufacturing systems’. The guide is applicable to both new and existing manufacturing systems throughout their total lifecycle, from concept to retirement; and may be used for the implementation of changes to existing systems and their continuous improvement during operation. Avenio’s 3-way approach to lifecycle modeling (identification, characterization & verification) is an exact fit for ASTM E2500 and the company is actively discussing implementation assignments with its expanding client base.
Write a comment