BioPhorum Interchangeability Assessment And Qualification Best Practice Guide

As single-use components (SUCs) become increasingly central to biopharmaceutical manufacturing, the need for standardized interchangeability practices has never been more urgent. This ebook offers a structured framework for evaluating SUC changes—from identical replacements to functional modifications—through fit, form, and function (FFF) assessments and risk-based evaluations. It outlines both proactive and reactive strategies for managing substitutions, with clear roles for suppliers and end-users. Learn more about supply chain resilience to gain insight into traceability, documentation, and supplier approaches like variable bills of materials (vBoMs) and generic SUCs. Practical tools such as attribute templates and case studies help teams apply these principles effectively.

For organizations navigating complex change management and regulatory expectations, explore a path toward more flexible, compliant, and uninterrupted manufacturing.