By now, everyone in the pharmaceutical industry should be thinking about serialisation. November 2017 will be here sooner than we think and, by then, everyone manufacturing drugs in — or exporting medicines to — the United States needs to be ready for the Drug Supply Chain Security Act (DSCSA).
Pharmaceutical companies and other supply chain stakeholders need to prepare, check and provide a variety of compliance data as drug products are shipped, received or analysed by operating facilities. This can create significant technical challenges for compliance systems, which need to not only manage massive amounts of data, but also be ready to respond (at operational speeds) to queries from a diverse set of business systems.
Serialised product return verification under FDA’s DSCSA is one example of an emerging challenge wherein operational processes from one industry stakeholder (the wholesale distributors) can be tightly coupled with the compliance system of another stakeholder (pharmaceutical company).
Whereas current serialisation requirements are limited to marking the unit of sale with a unique data carrier, by 2023 the process will require a product to be traceable through the entirety of its journey — from the individual package through the carton/pallet to its final point of distribution.
Level 3 systems shine when no human interaction in the serialisation or track and trace process is expected
In the United States, the Healthcare Distribution Alliance (HDA) is suggesting that pharmaceutical companies begin to support this level of serialisation, called aggregation, now. Around the world — in Europe and Asia in particular — disparate track and trace practices are incrementally moving toward a global standard that will, undoubtedly and inevitably, be more stringent than today’s differing benchmarks.
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