Saved by the Delay - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Saved by the Delay
Postponement of California's deadline gives the supply chain time to refine ePedigree solutions.


Pharmaceutical Technology
Volume 32, Issue 8

Benefits beyond compliance

The goal of pedigree efforts and laws is to ensure a safe supply chain free from counterfeit product. Some companies only seek compliance. Others view pedigree implementation strategically. Indeed, once product serialization and pedigree record-keeping are in place, previously unavailable supply-chain data can be used in many beneficial ways. For example, one manufacturer increased revenue by halting a parallel trading operation that was diverting product sold overseas into the United States.

Serialization also offers the potential for faster, more precise, and less costly recalls than are currently possible. Recalls tend to be a largely manual process. "You never know if you're done," says Peter Spellman, senior vice-president of products and services at SupplyScape. "A pedigree system can immediately tell you how much of an affected lot was on hand and where it was sent," he explains. "What normally takes days can be accomplished in 15 minutes," he concludes.

Other advantages of serialization include improved inventory management, particularly expiration-date management, expedited payment, and efficient processing of returns.

Although members of the pharmaceutical supply chain can assemble their own systems, some suppliers have collaborated to offer a turnkey solution. Products include the "California Express Solution," which consists of enterprise software from HP (Palo Alto, CA), preserialized packaging from Nosco (Waukegan, IL), ePedigree software from SupplyScape, a packaging-execution system from Systech International (Cranbury, NJ), the "PharmaTrack" serialized distribution solution from Acsis (Marlton, NJ), and serialization strategy and services from VeriSign (Mountain View, CA).

Solutions for electronically capturing pedigree data at various supply-chain points are being brought to the market. One system that supports linear barcodes, 2D barcodes, and RFID tags is available in tabletop, conveyor-mounted, and mobile-cart configurations. The system creates the initial ePedigree; aggregates items into cases, totes, pallets, orders, and shipments; verifies the ePedigree and completeness of incoming goods; updates the pedigree of items being shipped; and provides quarantine or special handling ("Blue Vector Serialization Station," Blue Vector Systems, Palo Alto, CA).

Decisions about suppliers must be made soon to ensure timely delivery and implementation. Waiting 8, 12, or 16 months to place an order could easily double or triple lead times because of order volume.

Although counterfeit prevention is the goal of pedigree requirements, it should be noted that serialization and tracking must be supplemented by physical authentication features because it is "inevitable that serial codes from legitimate product will be copied and used on counterfeit product. The capability to authenticate both the serial code and the physical item quickly, definitively, and in the field will be a critical component of a complete product surety initiative" (2).

Hallie Forcinio is Pharmaceutical Technology's Packaging Forum editor, 4708 Morningside Drive, Cleveland, OH 44109, tel. 216.351.5824, fax 216.351.5684,
.

References

1. "Identification and Coding of Pharmaceutical Products in Europe," position paper, European Federation of Pharmaceutical Industries and Associations, Brussels, June 2008.

2. J. Rittenburg, "Authentix Comments to the European Commission, Enterprise and Industry Directorate-General, Pharmaceuticals," European Commission, Brussels, May 7, 2008.


ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
27%
Oversee medical treatment of patients in the US.
12%
Provide treatment for patients globally.
8%
All of the above.
46%
No government involvement in patient treatment or drug development.
7%
Jim Miller Outsourcing Outlook Jim MillerCMO Industry Thins Out
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerFluorination Remains Key Challenge in API Synthesis
Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
Sean Milmo European Regulatory WatchSean MilmoHarmonizing Marketing Approval of Generic Drugs in Europe
Seven Steps to Solving Tabletting and Tooling ProblemsStep 1: Clean
Legislators Urge Added Incentives for Ebola Drug Development
FDA Reorganization to Promote Drug Quality
FDA Readies Quality Metrics Measures
New FDA Team to Spur Modern Drug Manufacturing
Source: Pharmaceutical Technology,
Click here