What is it and why it’s vital in the Supply Chain.
The biggest challenges in the pharmaceutical industry continue to be the battle against black-marketeering and counterfeiting especially when it comes to product serialization and traceability. Pharma serialization and traceability has been the focus in implementing and accelerating the publication of pharma tracking system regulations of all countries in the world.
As track and trace processes require records of every step of serialized drugs in the supply chain, it’s not feasible to move drugs through the supply chain one at a time and individually. It’s through Pharmaceutical Aggregation that there’s a connection between the SSCC of the tertiary packages and the serial number of all the drugs and packages in the stages of pharmaceutical production. As drugs usually move with tertiary packages among stakeholders, in a supply chain without aggregation, all stakeholders are able to access serialized data only through irrational operations.
Supply chain operations use tertiary packages such as bundles, cases and pallets via a parent-child relationship for easy access to serial numbers on them. This makes it easy to access the tertiary packages without opening them. Pharmaceutical Aggregation is pivotal here as it provides access to serialization data of drugs within tertiary packages via SSCC which enables supply chain operations.
It’s believed that most commonly occurring errors in projects happen when there’s a disregard of the pharmaceutical aggregation process, especially when preparing URS documents after the serialization requirement. DSCSA and EU-FMD have already indirectly defined aggregation for pharmaceutical products. Many pharmaceutical manufacturers began working on and implementing their integration efforts right from the start.
When a serialization project is designed without considering aggregation process requirements, it is very likely to fail and in some cases it may even somewhat partially succeed. This is why pharmaceutical aggregation is so crucial.