White Paper

Is Your CMO Ready For Serialization And Aggregation?

Source: AbbVie

By Lloyd Mager


In the continuous improvement environment of pharmaceutical development and manufacturing, efforts to secure and enhance the supply chain include serialization and aggregation to exert more control over packaging, shipping, and distribution to enable traceability of finished drug products.

The U.S. Food and Drug Administration is halfway through its 10-year period to establish “an interoperable, electronic product tracing system at the package level” as part of the Drug Supply Chain Security Act (DSCSA). The purpose of the 2013 act is to identify suspect or illegitimate products in the supply chain, while also enabling manufacturers to notify FDA of any potentially dangerous products in supply.

Most recently, in February 2018, as part of DSCSA, FDA issued draft guidance on standards for the “interoperable exchange of transaction information, transaction history and transaction statements (product tracing information)” among trading partners. These exchanges must be electronic-only by 2023.

“With a dedicated traceability operation within the company, and serialization efforts in place, AbbVie has prepared a long-term strategy to address aggregation.”