Drug Serialization and Supply-Chain Security - Pharmaceutical Technology

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Drug Serialization and Supply-Chain Security
As regulators work to curb counterfeiting, industry finds benefits to gaining granular data about the supply chain. This article contains bonus online-exclusive material.


Pharmaceutical Technology
Volume 33, Issue 6

Supply-chain security software. Systech International's (Cranbury, NJ) packaging execution system (PES) works on a company's packaging line to enable product authentication and track-and-trace capabilities. The PES is designed to integrate with any business management software and work with any data carrier.

"The main objective of a packaging line is getting product out, and a company's IT department is concerned with maintaining the integrity of the data; we address both of these issues," says Joe Ringwood, chief operating officer. "Systech's goal is to get a serial number on each item and then get that information to the business system."

Products and solutions from Acsis (Marlton, NJ) focus on serialization, data collection and management, track and trace, and optimization of supplychain activity to increase efficiency of manufacturing and distribution processes. Among the company's products is the serialized distribution application PharmaTrak, which allows companies to track products using serialized barcodes and RFID tag labeling. Andre Pino, vicepresident and chief marketing officer at Acsis, sees a trend toward gaining more data about the supply chain, saying, "RFID and serialization has been traditionally associated with anticounterfeiting, but now we're starting to see that it offers other benefits such as optimization." The company's services also include compliance and brand protection.

Axway's (Phoenix, AZ) vertical solution for healthcare, its Synchrony Solutions suite, provides community management, visibility, and policy-management solutions. This includes eSubmissions to FDA and EMEA, ePedigree, track and trace, and business activity monitoring. The Synchrony solutions have been selected by several top pharmaceutical companies: GE Healthcare chose the ePedigree component, and both AstraZeneca and Genzyme chose the supply-chain integrity suite, according to news releases posted on Axway's website.

Kim Loughead, director of solutions marketing for track and trace at Axway, says the software "enables manufacturers to make data available to trusted partners, in all steps of the supply chain. This data can be used to secure the supply chain through enhanced visibility, to comply with global track-and-trace regulations, and also to optimize common supply-chain business processes."

SupplyScape's global traceability and serialization software solutions help companies protect against counterfeiting and diversion. The company's E-Pedigree and RxAuthentication applications center on brand protection and product traceability requirements. These solutions are supported by the company's Nexus collaboration platform, which is designed to improve business process collaboration between companies, their customers, and their supply partners. The company also has a consulting service that provides analysis and planning services for companies to improve supply-chain security, develop secure regulatory compliance programs, and project business value opportunities based on proposed supply-chain traceability investments.

Robin Koh, chief strategy officer at SupplyScape, sees two emerging trends in anticounterfeiting and supply-chain security efforts. "One very early trend in anticounterfeiting is to extend the umbrella of the traceability paradigm beyond the current finished dose supply chain. Even though coverage across this supply chain is far from complete, there is considerable energy going into two new areas. First, improving the visibility into and traceability of the inputs into the finished-dose products, notably the active pharmaceutical ingredients and excipients used in manufacturing. Second, extending the product authentication capability beyond the supply chain and into the consumer's hands via portals is an interesting new area. Given the rise of Internet pharmacies and the like, this kind of consumer empowerment may have a place at the table in the future. It also sets the stage for direct-to-consumer conversations of many types."

Conclusion

The integration of anticounterfeiting features and item-level serialization with the ability to monitor and manage supply-chain data can detect and combat counterfeiting. Regulations are moving forward, and in the meantime, many companies are improving efficiency by gaining a more complete understanding of their supply chain and using that information to implement protection strategies.

References

1. FDA, Standards for Securing the Drug Supply Chain—Standardized Numerical Identification for Prescription Drug Packages, (Rockville, MD, Jan. 2009), http://www.fda.gov/oc/guidance/drugsupplychain.html, accessed May 14, 2009.

2. Public comments on FDA's draft guidance for industry, Standards for Securing the Drug Supply Chain—Standardized Numerical Identification for Prescription Drug Packages, http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=FDA-2009-D-0001, accessed May 14, 2009.


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