At first glance expiry date calculation of packed finished pharmaceuticals seems common practice. You add the period in which the product remains stable (total shelf life) to the manufacturing date which results in the expiry date. But as always, the devil is in the details.
Customers around the globe can have a different interpretation of the total shelf life of a certain pharmaceutical product. For example, the same product can have a total shelf life of 3 years in Europe, but only 2 years in Asia.
This can result in the same product having a different expiry date depending on the customer or region the product is shipped to. Also, pharmaceutical products can be packed with several sterile auxiliary materials (e.g water for injection). These components all have their own expiry date, and must be considered for the total package.
As you can see the calculation of the expiry date becomes more complicated, and mostly not supported by out-of-the-box systems.
Figure 1: Graphical display of possible expiry date requirements around the world
A use case: Combining Business and SAP knowledge
Together with our customers, itelligence developed a tool within SAP ERP, to support the complex expiry date calculation process as described above.
“Making the process more efficient and decreasing the risk, are the main goals of this development.”
The tool had to replace a manual calculation process that was prone to errors and very time consuming. So, not only does the tool support GxP compliancy, it also decreases manual labor activities.
The tool, that is based on SAP batch derivation functionality, can deal with all requirements displayed in the figure below, and can be easily extended with additional specific demands. Also, because it calculates the expiry date before the product is packed, data could be interfaced to packing lines and labelling machines for further optimization.
Altogether, we have succeeded to implement a tool that helps our customer to be more efficient and GxP compliant.
“A Higher patient safety level captured in a more efficient process!”