One of the most intense questions about any serialization mandate is whether or not manufacturers would be required to pass “aggregation data” to their customers. “Aggregation data” is the serial number-based packaging hierarchy of the shipment. That is, a list of the package-level serial numbers that are contained in each serialized bundle, and then which bundles are contained within which serialized cases and then which cases are contained on which serialized pallet, etc.
You can’t expect to give a couple of workers a handheld barcode reader and expect them to produce six sigma aggregation data. It is possible to collected highly accurate aggregation data (see “Pharma Aggregation: How Companies Are Achieving Perfection Today”), but it requires systems specifically designed to do so. The now obsolete California pedigree law did not Continue reading Does The DQSA Require Manufacturers To Provide Aggregation Data? Survey Says…