Many countries prescribe both serialisation and the aggregation of secondary packaging into packaging hierarchies to allow the seamless tracking of medicines throughout the entire logistics chain — thus accomplishing end-to-end track and trace capability. This entails comparing the previously serialised individual packs with the serialisation database during the manual or mechanised packaging process to produce what are known as parent-child relationships (Figure 3).
In the case of packaging by machine, defective and illegible packs can repeatedly impede successful aggregation and will need to be exchanged manually at the end of the process. If necessary, the serialisation software must also be able to model these operations at Level 3. At the very latest, for the purposes of repackaging and order picking in the warehouse, it should be possible to partially dissolve or redefine the originally established child-parent relationships. For users who already, or may in the future, export to countries where a track and trace capability is mandatory, it is essential that the software and database solution accommodates these aspects. Such a requirement already exists in Turkey and is scheduled for implementation in the USA. Protocols such as EPCIS from GS1 seem to be a good standard for information interchange within the logistics chain. A suitable software solution should be prepared for that.
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