Abstract

As the product in company pipelines increase in number and reduce in expected patient numbers there is a need to move from large batch, high-speed lines, to agile units that can rapidly switch between products. These changes are leading to innovation and creativity from equipment suppliers, but in addition customers need more standardization and fewer proprietary systems to aid with interchangeability, reliability and unit cost reduction. To make this happen in good order users need to ask for similar capabilities, using the same language to create necessary pull to influence equipment suppliers. This URS establishes an industry benchmark of flexible filling needs and serves to streamline the acquisition and approval of new equipment by pharma company leadership. It will enable the industry to bring products to patients faster and reduced costs through use of standard components and processes. Ultimately, enabling organizations to develop small-batch capabilities in preparation for the future of personalized medicines.