‘ePedigree’ and ‘Serialization’ have become hot topics in the world of pharmaceutical and medical device tracking. But how many of us really understand the difference between the two?
ePedigree
ePedigree is based around creating an electronic record surrounding chain of custody and chain of ownership (sale) of prescription medicines and medical devices within the supply chain. It contains information on all transactions from the time a pack or logistics unit leaves the manufacturer to the point it enters a pharmacy or someone dispenses the drug. Encompassing the entire shipping and wholesale process, it critically includes wholesalers who may be responsible for repackaging into other unit levels e.g. from pallet to case.
Mass Serialization
Mass Serialization is about allocating a unique serial number to all products at the item level – sometimes referred to as a UID (unique identification). Traditionally, numbers or identifying codes would be sequential, but as part of an anti-counterfeiting initiative this is inadequate. Sequential serial numbers can easily be predicted by counterfeiters and replicated along with batch / lot codes and expiration dates. Therefore a mechanism needs to be in place to allocate random numbers so they are non-predictable.
In the case of pharmaceutical serialization it’s normally on secondary packaging such as patient pack or retail level (carton). Where appropriate it can be on primary packaging such as a blister. While creating a system for generating, allocating and encoding products is complex, it brings many advantages for track and traceability. This applies to combating counterfeiting and wider business process improvement within the internal and external supply chain.
Bringing ePedigree and Serialization Together
There is some overlap between the two methods. ePedigree can carry data about serialized product and packaging as part of the transaction record. In the US, the FDA has already put forward a guidance to serialize products at the item level. This item level data can be linked to the initially larger aggregated packages which carry their own unique identity. As packs get split or de-aggregated and moved onto other supply chain ePedigree records, the serial numbers and their initial pedigree can be linked and traced back to their origin.
For more information on ePedigree and Serialization, visit Prisym ID
