Single-use technology is growing fast in the biopharmaceutical industry, but designing new single-use systems involves a long, iterative process between end-user and supplier to ensure quality, regulatory, and technical requirements are met. Wouldn’t it be convenient if all these requirements were captured in a toolkit? BioPhorum and BPSA have created templates aligned with industry standards (i.e. ASTM E3051) which will simplify the single-use design process. The Single-Use User Requirement (SUUR) Template helps end users to communicate process/application details and SU requirements to suppliers, who in return can affirm or describe their capabilities to meet these requirements. The Technical Diligence Templates are pre-populated with end-user requests for detailed information that describes how suppliers may fulfil specific user requirements. Supplier responses allow end users and suppliers to make informed decisions and reduce gaps in understanding. The Supply Chain Template allows end users to request supply chain-related information and gives suppliers with a dedicated document to respond to this request. These templates combine to provide the industry with a set of common user requirements, clarity on criteria for fulfilling these requirements, and a mechanism for transmitting supply chain-related information. Adoption of these templates will yield distinct advantages to both end-users and suppliers in terms of compliance, time, and efficiency. Quality and compliance is improved by documenting and aligning expectations. Further, the tools enable clear and consistent communication, fostering a right-first-time approach to the design of single-use components.
single-use user requirements
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