In part two of the series, we focus on the impacts of the SA25’s operating principles, which combine to radically reduce and simplify manufacturing documentation. As we all know, the documentation requirements for cGMP manufacturing are extensive. Despite advances in automation and digital technology, the pharma industry has continued to rely heavily on legacy paper-based systems. Singota’s choice of the Vanrx SA25 Aseptic Filling Workcell was in part based on the way this system facilitates both the simplification and reduction in volume of batch documentation.
Anyone responsible for the management of the supply chain to support a pharmaceutical or biologic clinical trial can appreciate the challenges associated with an unexpected or otherwise urgent need to produce clinical drug product. Many factors can conspire to make a rapid response to such an urgent supply situation challenging. This article is the first in a series that describes some of the challenges and solutions available to pharmaceutical/biotech companies and their supply chain partners in the CDMO realm to ensure that critical clinical supply materials are ready when they are needed.
We can utilize technology to track the status of online purchases or the current location of our vehicles, smartphones, and even friends and family members. It would make sense then that we would want to take advantage of these same types of technologies as it pertains to the risk mitigation of our sensitive and high value pharmaceutical shipments.