14 August, 2018 by Carla Frances Reed, President, New Creed
In 2011, I wrote a paper titled,” Beyond the Mandates,” with the intent of outlining how the proposed regulations for mass serialization (imminent for implementation with different global timelines) could provide additional value for overall supply chain visibility. Seven years later, the debate in terms of when and how to implement a combination of mass serialization, wireless networks and event management technology continues with the desired outcome to provide the Holy Grail of Supply Chain Management — real-time visibility across the chain of custody.
The regulations have changed – expanded and become more formal in many areas – but there are still challenges to be met and additional opportunities to exploit.
There is a lot of hype related to the ‘so-called’ Internet of Things (IoT) – which is basically an ecosystem that supports the increasing ubiquity of smart devices, sensors, smart labels (integrated RFID imbedded into human readable and barcoded adhesive labels). At a simplistic level, the “data management, sharing and process facilitation” has moved from devices into a web-based series of applications that are accessible to many trading partners through shared applications and alerting tools.
This technology platform enables the goals expressed by regulators in the life sciences industry of having a digital audit trail for each of the transactions that support the movement of raw materials, API, drug substance, drug product and finished packaged pharmaceutical and biotech products across an extended chain of custody and into the “point of patient” or chain of care.
Additional capabilities that are facilitated by web-based applications relate to the time and state of materials and products with defined workflows and alerting mechanisms enabling proactive intervention for an adverse event. This is especially relevant for the growing number of exploratory compounds and drug products in the evolving biotech industry where most shipments are sensitive to environmental conditions and extremely short shelf lives.