BioPhorum, in collaboration with the BPSA, has published an updated edition of the Single-Use User Requirements (SUUR) Toolkit – Implementation & Use. This update reflects both current regulatory expectations and the practical experience gained since its original release in 2019.
So what is new and why does it matter?
✔️The updated guidance is now aligned with ASTM E3051-25, EU GMP Annex 1 and BPSA Quality Test Matrices
✔️It contains practical, step-by-step recommendations for implementing SUURs across organizations and supply chains
✔️It has an expanded focus on cross-functional engagement between manufacturing, quality, engineering, sourcing and suppliers
✔️It contains clear guidance on how to use the SUUR template and optional supply chain memo to improve transparency, reduce rework and accelerate 'right first time' execution
✔️It includes real-world considerations for rollout, governance and change management.
Developed collaboratively by end-users and suppliers, this update reinforces SUURs as a foundational best practice for designing, qualifying and implementing SUS in today’s regulatory and supply-constrained environment, and will help drive consistency, transparency and confidence across SUS design and supply.
Learn more and download the toolkit here https://lnkd.in/egy2-UCx