The major markets for pharmaceuticals have been forever transformed with the arrival of mandated serialization. With both the United States Drug Supply Chain Security Act (DSCSA) and European Union Falsified Medicines Directive (FMD) now “live”, the pharmaceutical supply chain is forever tied to serialized products and data. When looking deeper, a successful serialization program involves far more than just placing serial numbers on packaging.
Regulations differ between markets and can change often—meaning regulatory professionals must be prepared to adjust processes, procedures and filings to keep up. Since pharma serialization and tracing regulations are relatively new, they are subject to greater global diversity and change more frequently than other regulations.
Serialization is an ongoing program, requiring ongoing investment and attention. Although major regulatory deadlines have passed, serialization hasn’t “ended” but transitions into an essential practice within the entire industry, touching manufacturing and the broader supply chain. The serialization “office” will need to live on.
One of the realities of the DSCSA is its phased implementation approach. First, we started with serializing “eaches”. Now the pharma supply chain must comply with the DSCSA’s Salable Returns Verification mandate. Though this moved out one year from an enforcement perspective, manufacturers and distributors of regulated medicines need to be compliant—or at least on a path to compliance—when enforcement begins in November of this year (2020).
One area of practical importance that involves serialization is aggregation. Though not specifically called out in regulations, it is absolutely part of the serialization umbrella. Aggregation is a technique used in conjunction with serialization that establishes and records the relationship between a serialized object and its container(s), which also is serialized. Think serialized units packed into a serialized case loaded and wrapped onto a serialized pallet. One scan of the serialized barcode label of the pallet “moves” all the aggregated cases and eaches with it.
Aggregation is looked at as central to the DSCSA “interoperable supply chain” mandate for 2023. This is the next major hurdle of regulatory compliance. The exact requirements have not been finalized, but it is certain to have aggregated products at the core to facilitate information gathering and better traceability up and down the supply chain.
Gaining Value from Serialization: Efficient Internal Operations
Serialization 2.0 involves deriving insight from visibility into serialization operations and mining that data. The process of moving towards item-level traceability through serialization enforces data integrity through a series of strict process rules and adherence. Serialization provides manufacturers with the potential to gain improved visibility and control over internal operations, leading to efficiencies that can generate significant cost savings.
Addressing inventory leakage – A multitude of factors impact leakage as products move from manufacturing to packaging and on to shipment – these include labeling issues, quality sampling, human error and employee theft. Under batch packaging, reconciliation of production and shipped product is an arduous and often impossible task.
The process of creating product identity through serialization offers manufacturers a means of tracing a product’s journey through each stage of the packaging process and internal movement. In capturing this information, manufacturers can gain the requisite insight to quantify the root causes of product leakage. Once these causes have been identified, corrective action can be taken.
Automating inventory control – The automated inspection and verification that forms parts of the serialization process affords manufacturers the ability to reduce if not eliminate the need for manual counting and data entry. This drives a higher degree of accuracy and timeliness in inventory reporting and reconciliation.
Print and template management – Mislabeling is a common cause of product recalls. Printer management and inspection as part of the serialization process allows manufacturers to ensure that each product is appropriately labeled
Managing packaging assets – Data collected through serialization can be utilized to accurately capture and manage the economy, efficiency and capacity of different packaging lines’ internal and outsourced assets. In addition, the overall equipment effectiveness (OEE) can be monitored with a much greater level of accuracy by using the serialized data for root cause analysis.
Creating a cross-line consolidation of serialized product and operations data is vital to get the most out of one’s serialization investment. This not only enables better data integration with outside entities, like regulatory bodies, but provides new analytics and reporting opportunities for driving operational excellence. Serialization 2.0 transforms serialized data from a static compliance repository into an active business-changing engine.
Interested in gaining greater insight into Serialization 2.0? Attend this upcoming Systech-sponsored webinar: Use Serialization Data to Maximize Performance and Minimize Risks.