Is Your CMO Ready for Serialization and Aggregation?
Author: Lloyd Mager, Senior Program Manager, Strategy
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Most recently, in February 2018, as part of DSCSA, FDA issued draft guidance on standards for the “interoperable exchange of transaction information, transaction history and transaction statements (product tracing information)” among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.
Last year, the agency issued draft guidance around the use of product identifiers, to ensure individual (salable) prescription drug packages are marked with unique IDs that can be easily traced as they move through the supply chain from manufacturer to dispensary. Each ID would include the product’s lot number, expiration date, national drug code, and a serial number, and must be both human and machine readable. Enforcement of the identification requirement has been delayed to late 2018 for products that have not yet been serialized to give manufacturers additional time to comply with the recommendations, and to avoid supply disruptions.
The ultimate goal is to maintain control, via the ability to track and trace the salable unit of a prescription drug from its manufacturer to the patient. The FDA’s approach to traceability seems to be a collaborative effort with industry to develop standards, and for industry to develop processes, that will address the overall goal of safety, security, and continuity of the supply chain.
AbbVie has been an active and leading industry participant in these conversations, applying traceability, serialization, and now aggregation standards to our operations in both our pharmaceutical manufacturing and contract manufacturing businesses.
The company adheres to standards from GS1, a neutral, global non-profit standards organization that brings efficiency and transparency to the supply chain. AbbVie’s processes comply with GS1’s Global Traceability Standards for Healthcare, in order to trace backward to know the history of transfers and locations of a product from the point of manufacture, and to track forward to see the intended route of the product to the point of care. AbbVie also participates in the Prescription Drug Security Alliance and its efforts to shape and implement processes to comply with guidance and regulations. Traceability and verification of product is a global effort, as countries worldwide are in varying stages of applying requirements to enhance the supply chain. As a supplier of pharmaceuticals to international markets, AbbVie’s traceability efforts are designed to comply with global regulations and standards.
Long-Term Aggregation Strategy
With a dedicated traceability operation within the company, and serialization efforts in place, AbbVie has prepared a long-term strategy to address aggregation.
Aggregation is the process of building a data relationship between unique identifiers for salable units, the cartons they are packed into, and then the cases and pallets into which they are subsequently packed and shipped. Using that data, manufacturer distribution operations can “infer” that the correct product and quantity are enclosed in each carton, case, or pallet without opening each for inspection.
Inference generally is a practice that allows a conclusion to be reached based on presented facts; with serialized inference, a supply chain partner can use inference to facilitate efficiency in the receiving of items without physically reading each serialized identifier at the time of receipt.
Such inference expects aggregation to be perfect, and perhaps over-relies on the accuracy of aggregation data to enable a digital trade model. For this reason, AbbVie is also focusing on improving inference and data integrity practices.
Although aggregation itself is not an explicit requirement of DSCSA, it is the enabling technology for inference in the supply chain and, therefore, an essential component to assure market continuity and product supply. A reliable aggregation process strengthens operational practices and creates the kind of checkpoints and controls that give integrity to the supply chain.
By developing an aggregation solution that meets market and operational requirements at our packaging sites, AbbVie supports global market compliance and data integrity. Market requirements are demanding new functions and features on existing packaging lines. Therefore, plans at AbbVie call for multiple packaging lines in four locations across North and South America and Europe to be ready for aggregation by 2021. Some locations, because of customer demand, are ready now.
To prepare itself for the digital supply chain and electronic data flow for regulatory interoperability, AbbVie has created the portal Trace@AbbVie to provide access. The web portal provides visibility of data, performs as an interface for stakeholders, and is used to understand system performance, provision data externally, and respond to external product verification requests. Trace@AbbVie helps the company leverage data for multiple supply chain activities to facilitate product flow. This includes exchanging master data, commission data, and transaction event data with trading partners, for government reporting, and external queries.
Here to Stay
Aggregation is not a topic that is going to go away. It is a logical continuation of the FDA and industry’s efforts to secure and strengthen the supply chain. While some are waiting for mandates for traceability, serialization, and aggregation, others are recognizing the inevitability of these strategies. Companies that questioned the need for aggregation in the past are now starting to look for this service. On top of the ability to serialize product, you must have the ability to create these parent/child data relationships, using aggregation, and do it accurately.
For a reliable supply chain partner that is investing in its future, talk to AbbVie Contract Manufacturing via email: email@example.com, website: www.abbviecontractmfg.com or by phone: 1-847-938-8524.
 The Practice of Inference in the U.S. Pharmaceutical Supply Chain, Release 1.0, GS1, May 2010.