What Your CMO Needs To Know About Serialization And Aggregation

Source: AbbVie

By Iryne Ng & David Zimmerman, AbbVie Supply Chain Traceability Operations

Drug Serialization

In recent years, the global pharmaceutical industry has been under intense pressure to enhance the safety, security, and continuity of the supply chain. This has required drug manufacturers and a vast range of supply chain partners to work collaboratively to improve supply chain transparency. The goal is to be able to track, trace, and authenticate products, and to assure prescription drug supply from the manufacturer to the patient.

Serialization lays the foundation for delivering on these objectives by assigning each saleable unit a unique identifier to aid in identifying suspect or illegitimate products within the supply chain. Aggregation takes serialization one step further by building a comprehensive data relationship between the unique identifiers for saleable units, the cases they are packed into, and the pallets on to which they are subsequently loaded and shipped.   

Partnering with a CMO that has applied traceability, serialization and aggregation standards across its own operations promises business continuity and speed-to-market that translate to a competitive advantage. AbbVie’s traceability efforts are designed to comply with global regulations, and we adhere to standards from GS1 (a neutral, non-profit organization that develops and maintains global standards for business communication to bring efficiency and transparency to the supply chain*) as well as participating in the Prescription Drug Security Alliance and supporting its efforts to shape and implement processes to comply with guidance and regulations. With robust serialization efforts in place and a long-term strategy to address aggregation, AbbVie is your partner of choice to ensure there are no costly delays in getting your drug to the patients that need it most.

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