The A-Z of Pharma Aggregation Solution

An effective, stable, and efficient pharmaceutical traceability system is only possible with integrated serialization solution and aggregation solution. According to our observations, the frequent error in projects is the disregard of the pharma aggregation process. In fact, pharmaceutical track and trace system regulations prepared by all legislators define this process as direct or indirect. However, since it usually starts after the serialization requirement, project teams often overlook it when preparing URS documents. DSCSA and EU-FMD have indirectly defined aggregation solution for pharmaceutical products. However, many pharmaceutical manufacturers and project teams predicted this necessity and started integration efforts from the first day.

Unfortunately, a serialization project designed without considering aggregation process requirements is very likely to fail or partially succeed. We will try to convey the details and importance of this process in the ongoing sections of our article.

What’s the Meaning of Pharma Aggregation Solution?

The pharmaceutical industry has already been using tertiary packages (bundle, case, pallet) to facilitate supply chain operations.

This process provides easy access to the serial numbers of all packages within tertiary packages by establishing parent-child relationships. In this way, you can access the serial number of the package and drugs without opening any tertiary package.

For example;

Let’s assume that we placed 5 cartons with serial numbers 10, 11, 12, 13, 14 in an empty case. Then, by aggregating these serial numbers, let’s relate these numbers with SSCC and apply the SSCC label on the case. Now we can access serial numbers of drugs through SSCC without opening case at any point in supply chain. Pharma aggregation establishes a relationship between the SSCC of the tertiary packages and the serial number of all the drugs and packages in the pharmaceutical production process.

Traceability can be defined as tracking the points of a product across the entire supply chain with an electronic registration system. This electronic registration system can only be created by legislators or powerful non-governmental organizations. Because it can only be possible only upon the instruction of authority for all manufacturers to serialize their products and to enter the traceability records of all stakeholders in the market.

The pharmaceutical industry is the only industry in the world where the concepts of product serialization and traceability are completely applied. This industry has been struggling with black-marketeering and counterfeiting for years. Pharma serialization and traceability were successfully implemented in Turkey in 2009 for the first time in the world. This implementation has been an example of accelerating the publication of pharma traceability system regulations of all countries in the world. It is estimated that pharma tracking systems, which are still in their infancy in many countries, will be more important and functional after the current pandemic.

The country with the most successful implementations in serialization and traceability in the world is Turkey without hesitation. In the current situation in Turkey, end-to-end traceability implementations are made for medicines, vaccines, cigarettes, and plant protection products.