With sections of the Drug Supply Chain Security Act (DSCSA) beginning to take effect in 2017, many companies are looking for ways to integrate serialization into their existing lines.
When the FDA first announced its DSCSA, Apace Packaging had already begun their serialization effort according to California’s ePedigree Law. Faced with a choice when the DSCSA preempted that law, Apace decided it was best to move forward and become one of the first packaging companies to add a fully aggregated serialization solution.
As the drug supply chain has become more complex, threats to the safety and security of drugs have become more sophisticated; as such, the FDA has established DSCSA with the overall purpose of adding more accountability and transparency to the U.S. drug supply chain.
There are future plans to have electronic traceability at the sale level of a drug, but at present, the regulations are about the primary basis for oversight of how drugs move in the U.S. to prevent counterfeits, theft, diversion, and adulteration.
Elements of the DSCSA include product traceability, verification, and identification. The rules, which apply to dispensers, manufacturers, repackagers, and third-party logistics providers, among others, primarily cover prescription drugs in finished dosage form for administration to a patient without further manufacturing (such as capsules and tablets).
Electronic Product Code Information Services (EPCIS) is a GS1 standard enabling healthcare trading partners to securely share information about the physical movement and status of products as they travel throughout the supply chain. This event-based traceability answers questions related to “what, where, when and why” to provide detailed and accurate product information to key stakeholders, business partners, and regulatory bodies.
The EPCIS standard is intended to enable shared visibility of event data for ensuring compliance (for example, for the DSCSA) and supply chain security, and it can also provide operational efficiency benefits when shared information is used for improvements (e.g. more appropriate inventory management or response to nonconformances).
Apace’s process incorporates three components, so that all serialized packages are tracked continuously throughout packaging and shipment. Apace uses ROC IT Solutions for the warehouse portion, Optel Vision solutions at the packaging line level, and Oracle Pedigree and Serialization Manager (OPSM) for generating serial numbers and storing their EPCIS events (Oracle OPSM is the repository where information is stored). Apace also uses Oracle’s e-Business Suite (EBS) as its ERP system, handling billing, warehouse information, and accounting.
Apace Packaging operates its DSCSA-compliant, fully aggregated serialization solution in an integrated 7-step process.
- Batch startup
In the initial step, Optel Vision retrieves the product master data from Oracle’s EBS and requests serial numbers from OPSM that can be applied to the batch. EBS is being used as the single source of truth (SSOT) for that master data. When using multiple information systems, maintaining an SSOT is extremely important for consistency, so that when a status is updated for a certain serial number, that update propagates to the enterprise at large (i.e. all of the related information systems).
- Packaging process
Optel Vision applies serial numbers to each GTIN level (bottles, bundles and cases).
- Commissioning serial numbers & aggregating
During aggregation, the items are being packed on the line and Optel Vision is recording which serialized items are being packed into higher-level serialized items (i.e. packing bottles into bundles, bundles into cases, cases onto pallets, etc.). Once that complete hierarchy is captured, the information is then sent to the OPSM repository and that packaging structure is recorded for use in downstream processing (Steps 4-7). The commissioning portion communicates to OPSM that the serial number was affixed to an item. (A “commissioned” serial number is one that is in use in the supply chain, while a “decommissioned” serial number is one that has been removed from the supply chain.)
- Post-batch completion rework
Note: This step is performed when there is a need for rework or for rebuilding a damaged case or pallet, or for QA sampling. The packages originally sent from Optel Vision lines are being altered, for example, if a box has to be removed from a pallet, ROC IT Solutions’ Edge Data Processing System would receive the original hierarchy structure (from Step 3) and would then update the OPSM repository to reflect that the box was removed. This keeps the hierarchy structure current within OPSM.
- Shipping/receiving serial numbers to finished goods inventory
When the serialized product is received into inventory or transferred to another location (regardless of whether it is an internal transfer or transfer to another distribution center), Apace uses the ROC IT solution to process the event, scan the pallet tags, and then communicate the resulting EPCIS events to OPSM and the shipment/receipt events to EBS.
- Distribution Center (DC) rework
This optional step includes rework of serialized containers in the DC. Scenarios such as QA sampling and preparation for picking and packing orders for shipment are possible. For example, if a customer needs 10 boxes of Item A and 20 boxes of Item B, those items are removed from their original pallets (de-aggregated) and then packed or aggregated onto another pallet. Another rework scenario could result if a serialized container becomes damaged and needs to be altered in some way.
Regardless of the reason for rework, the data transfer is similar to that in Step 4 — OPSM's repository is updated by ROC IT in real time to tell the system that the items were removed from their existing hierarchy, and added to a new hierarchy.
- Distribution, invoicing and data transfer functions
After the shipping process is completed, ROC IT communicates with both the Oracle EBS and OPSM so that when the product is invoiced, the data transfer for the serial numbers and associated aggregation data can be sent to the customer’s data management system for their use.
Training and empowering
Apace Packaging recently completed its first year of running serialized lines and has returned to pre-serialization production speeds. Frank Guthrie, Director of Serialization and Operations at Apace, noted that focusing on training and empowering employees were both key to their successful implementation, along with consistent collaboration from vendors on the IT and warehouse portions.
Apace has implemented serialization on each of its four packaging lines (two bottle lines and two blister lines). The company has experienced significant growth over the past few years and is continuing to expand, with the addition of a new warehouse by the end of 2015 and plans to add another high-speed bottle packaging line in 2016.
“With the DSCSA law in effect and the requirement to have product serialized beginning in 2017, Apace is in a position to not only ensure our current customers are compliant but also ready to help other companies that may be struggling to find a viable partner who can serialize their products," said Guthrie.