Since the US Drug Supply Chain Safety Act (DSCSA) came into force in 2013, pharma companies have been required to harness serialisation to enhance the traceability of goods through the supply chain. However, the legislation also mandates that they will need to go further over the coming years, incorporating aggregation – meaning comprehensive product tracing down to package level – by November 2023.

In an article with BioPharm, Staffan Widengren, director of corporate projects at Recipharm explains the process of creating a global programme for widespread serialisation and aggregation capabilities across its 15 sites.

Manufacturers are the first step in the serialisation process. As such, they must be the first ones to have serialisation and aggregation in place for the essential data to be accessed by downstream partners.

Pharmaceutical companies looking to serve the US market must start implementing new aggregation processes now, adopting new technologies and getting the expertise on-site to meet the regulatory deadline.

With serialisation, some global CDMOs took steps to implement the technology early, ensuring they were ready in advance of the regulation coming into effect. Now with aggregation, forward-thinking development partners are already integrating the approach into their processes to continue to support customers in maintaining regulatory compliance as we near the deadline. But what does this integration involve, and how can it be achieved efficiently?

 

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