You may have received letters from your distribution partners regarding DSCSA compliance and aggregation over the last few years. The Big 3 have specified dates from late March to early April for 100% of products to contain serialized data and be fully compliant. They also request an expected date for full aggregation.
Aggregation is the process of assigning “children” to a “parent” in packaging to more easily track and trace individual products throughout the supply chain. Packaging hierarchy rules specify what package types can be packed into other package types (boxes into case, cases into pallet, etc.), enabling one pallet barcode ID to represent all the unique products in all the cases on it.
While the DSCSA does not explicitly require aggregation, the FDA recognizes it as an essential process in pharmaceutical supply chains and data management—and all major players in the industry are aligned on the need for it. If you think about the sheer volume of product that passes through the Big 3 wholesalers each day, – it becomes clear that it would be close to impossible to adhere to compliance without aggregation data.
When we spoke to Gregg Gorniak of Cencora back in October, he said to imagine 1% of products being quarantined due to data discrepancies—just 1%! That would be a huge hit to our supply chain and an even bigger impact on patient care. When you look at it this way it’s clear how crucial aggregation data is as well as the flexibility of supply chain rework and a solution for managing exceptions that will arise.
Choosing a solution provider with a full stack approach is best suited to ensure you are ready and to keep product moving to the patient. Systech has been implementing proven, standardized aggregation solutions since the beginning and is here to partner with you on this compliance journey from L1-L5. Our flexible, feature-rich rework and exceptions management provide a full-featured, all-in-one solution.