McKesson, Cardinal, and AmerisourceBergen want it. The governments of Korea, Turkey, and Argentina own it. And the FDA sees it as vital to the future for the U.S. drug supply chain. What is it? The serialized data exchange, the next-generation pharmaceutical commerce practice that will ultimately identify and follow (or track-n-trace) every prescription drug product in the supply chain, from cradle to grave.
You can think of the pharmaceutical industry as a large group of partners in a supply chain, which creates a complex mix of relationships. The nature of data exchange means that the information is being shared – someone is providing it, and someone is receiving it. What information is shared and how it is shared varies a great deal from relationship to relationship, partner to partner. To help put all of this in perspective, I’ll approach serialized data exchange from the perspective of these supply chain partners:
- Contract Manufacturing Organizations and Contract Packaging Organizations (CMOs and CPOs)
- Third-Party Logistic Providers (3PLs)
- Wholesale Distributors
CMOs and CPOs
CMOs and CPOs are taking increasingly more important roles in pharmaceutical manufacturing because they can help manufacturers gain efficiency, scalability, and flexibility. And in the age of the DSCSA, CMOs and CPOs are critical partners in enabling manufacturers to reach comprehensive serialization compliance. To achieve this, CMOs and CPOs need to receive pre-packaging serial numbers or a range of pre-packaging serial numbers from the manufacturers, then provide the packaged serial numbers back to the manufacturers when the batch is released or shipped to the manufacturers.
Manufacturers are responsible for product quality, data quality, and adverse events. They are the gatekeepers of serialized data for drugs that are entering the supply chain. And they must manage data coming from various sources – including internal and external manufacturing facilities – that will then end up at various destinations, including 3PLs, wholesale distributors, and healthcare facilities. For manufacturers, there are several serialized data exchange touchpoints in the supply chain. They must:
- Provision serial numbers to CMOs and CPOs and receive packaged serial numbers from CMOs and CPOs
- Receive provisioned serial numbers from marketing authorization holder (MAH) partners and provide packaged serial numbers to MAH partners
- Provide bulk shipment serial numbers to 3PLs
- Provide parcel shipment serial numbers to wholesale distributors
Similar to CMOs, 3PLs offer efficiency, scalability, and flexibility to manufacturers from a distribution standpoint. Every 3PL has a number manufacturer customers, each with different needs. Some of those manufacturing customers require the ability to capture the serial numbers associated with each shipment, while others don’t. Some manufacturers need the 3PL to provide data exchange to wholesale distributors, while some integrate into the 3PL’s system and operate exchanges on their own. So even if the 3PL doesn’t use the capability in every situation, in the serialization world, they need to be able to exchange serialized data with both manufacturers and wholesale distributors.
Wholesale distributors exchange data with manufacturers, secondary distributors, pharmacies, and healthcare facilities. As discussed in my last four blog posts, where I analyzed serialization requirements from U.S. wholesale distributors, the big three all want serialized data exchange from the manufacturers, but at different points in the DSCSA timeline. Without a national centralized database that can functional as a clearing house for serial numbers, wholesale distributors are resorting to building out their own data repositories for the purpose of handling returned resalable products as well as helping them prepare for the future DSCSA track-n- trace requirement.
Meet DSCSA Compliance and Serialization Requirements with LSPediA
Despite well-laid plans in the industry and the comprehensive nature of the DSCSA, complexity is popping up in unexpected places. Serialization implementation requires an organization-wide strategy and careful navigation – one small oversight at any point can end up costing you significant time and money. A trusted partner – to act as advisor and implementation project manager – can make all the difference. And LSPediA is the partner of choice for a growing number of pharmaceutical companies.
The time to begin serialization is now. Starting for as little as $1000 a month, we can give your company compliance piece of mind – and a competitive edge. Contact us today.
LSPediA helps pharmaceutical manufacturers and distributors implement serialization and aggregation processes to meet global regulations, DSCSA requirements, and future track-and-trace mandates. Our services include URS, RFQ, gap analysis, serialization toolkits and solutions, DSCSA strategies, management consulting, and more.
We value long-term relationships and work with our clients’ internal teams to properly define roadmaps, create architectures, and implement systems that align to vital business goals, ultimately helping them derive maximum value from their investments, both now and well into the future.