The Partnership for DSCSA Governance (PDG) has been an important cross-industry independent initiative to ensure that all stakeholders impacted by implementing DSCSA have a resource to guide the industry to compliance. Systech is a member of PDG and has had our technical experts participate in developing and delivering the guidance and frameworks the group has published.
PDG has just delivered a resource on “Exception Root Causes”, documenting regularly expected “Misalignment Exceptions,” their likely causes, and example ways to mitigate them from happening.
I have written about how important this is before: DSCSA and exception handling — We need a plan
The November 2023 deadline for DSCSA compliance and its “interoperability” requirements mean the industry will truly have a parallel physical supply chain and data “supply chain.” Physical products will be reconciled upon receipt of the digital record of what was said to have been sent. When they don’t match, we have misalignment exceptions that must be addressed.
This PDG publication is great at articulating the proactive steps to avoiding exceptions in the first place. It is a “must-read” for manufacturers, wholesalers and pharmacies.
A lot of emphasis is being placed on getting the data integrations correct. The industry needs to ensure that adequate effort is made for TESTING of both perfect data and product situations and examples of inconsistencies and exceptions. Without acceptable misalignment exception handling testing, putting drugs in quarantine until the data is properly sorted out will be inefficient. It could lead to drugs sitting on a shelf and not being dispensed. Misaligned data could lead to medicine shortages and bad patient outcomes.
The exception-handling process across the pharmaceutical supply chain must be rigorously tested, with the resulting processes clearly documented and formalized.
Systech offers manufacturers the right tools to make sure the physical products match the digital transaction information sent to wholesalers. These offerings include rich, on-the-line rework capabilities for the inevitable times when a case or a pallet needs to be “fixed” physically and in the digital world.