Description:

Single‑use technologies have become integral to modern biopharmaceutical manufacturing, supporting faster, more flexible production in an increasingly complex regulatory landscape. Yet effectively communicating single-use system (SUS) requirements remains a challenge, often revealing gaps in expectations between end-users and suppliers. We wanted to equip industry with common tools to enable clear and consistent communication of user requirements and supplier capabilities. BioPhorum, in collaboration with BPSA, therefore published this updated edition of our toolkit to reflect current regulatory expectations and the experience gained since its release in 2019. The toolkit is a collection of standard templates to support SUS design and qualification, facilitating right-first-time implementation. It includes a user requirements template, supply chain memo template and a supporting ‘how to’ and implementation guide. It equips the industry with common tools to enable clear and consistent communication of user requirements and supplier capabilities when building SUS for an end-user application. So what is new and why does it matter? It is now aligned with ASTM E3051-25, EU GMP Annex 1 and the (2024) 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 includes real-world considerations for rollout, governance and change management. The toolkit adds significant value to the industry by establishing a common language and a structured approach for defining requirements and confirming supplier capabilities. This reduces misalignment, mitigates risk and supports faster, more robust SUS implementations."