How Electronic Pedigree Works
Certified Chain of Custody for Serialized and non-Serialized Product
A pedigree is a certified chain of custody detailing each distribution of a drug, from the manufacturer, through acquisition and sale by any wholesaler, 3PL, repackager or other distribution intermediary, until final sale to a pharmacy, hospital or other person administering or dispensing the drug. The result is a verifiable transaction history which can be used to proactively check the safety of drugs as they are received to investigate the history of a drug linked to adverse events such as counterfeit incidents.
The operational process in creating and managing electronic pedigrees is straightforward. As the manufacturer or their contract manufacturing / packaging representative prepares pharmaceuticals for shipment, an initial electronic pedigree is created. Data about the individual drug (including NDC, lot, quantity, expiration date, and serial numbers) and the initial transaction (trading partners involved, ship-from / ship-to addresses, etc.) is encoded on the pedigree and transmitted to the trading partner. All information on the pedigree is certified as being accurate and the pedigree data is secured from tampering.
The trading partner expecting to receive the drug shipment authenticates the pedigrees provided by their supplier through a pedigree systems self-authentication capability. When the shipment arrives, the pedigrees are matched to the products and signed verifying their accuracy. The verified products are then safe for inclusion into inventory.
Secure Product-to-Pedigree Mapping
Should an adverse event such as a recall occur, a company wants to be able to quickly identify the affected products in inventory. If an inspector visits and selects a product, the company must be able to produce the pedigree for that product. Or, when a company wants to sell product in inventory to a downstream customer, it must be able to retrieve the appropriate pedigree and supply it with the outbound shipment. In these cases and more, it is highly important to maintain secure and efficient product-to-pedigree matching. SupplyScape E-Pedigree manages the pedigree-to-product matching across a wide variety of operational processes so the correct pedigree can be quickly identified with serialized product inventory or even when the drugs don't have serial numbers. E-Pedigree manages the pedigree data in an optimized data repository available for quick retrieval and efficient maintenance by both E-Pedigree users and downstream trading partners which may use the web-based Pedigree Portal.
