Verify Brand, Rehrig Pacific and Intelleflex Address Calif. Board of Pharmacy

Verify Brand, Rehrig Pacific Co. and Intelleflex
PharmaManufacturing.com
01/10/2013

Representatives from Verify Brand, Rehrig Pacific Company and Intelleflex presented to the California Board of Pharmacy on December 4, 2012 to discuss how pharmaceuticals and logistics companies can deploy RFID and cloud-based data services for unit serialization and implementation of secure track-and-trace applications to meet pending e-Pedigree requirements. As the California deadlines of 2015 and 2016 for e-Pedigree and individual unit serialization approach, drug companies are seeking solutions for unit serial number tracking and case- and pallet-level unique identification. While GS1 standard 2D barcodes appear to be an obvious choice for the unit level serialization, the representatives noted that RFID is poised to become the preferred choice for case- and pallet-level monitoring and traceability.
 
Scott Pugh of Verify Brand, Kaley Parkinson of Rehrig Pacific Company and Peter Norton of Intelleflex delivered a presentation that focused on the benefits of an integrated approach that combines powerful RFID capabilities with track-and-trace software solutions and intelligent reusable transport items.  This approach would:
·   Provide an e-Pedigree that meets evolving government-mandated regulatory requirements using a flexible solution that can grow and change with the application in use to prevent disruption due to upgrades and version changes.
·   Provide a secure, safe, regulatory compliant and efficient method for track-and-trace throughout the supply chain while maintaining closed loop data and providing a source of data retention for applications where the closed loop becomes open distribution.
·   Deliver an efficient way to read product serial numbers, ownership and condition data immediately upon receipt and without opening or disturbing the packaging — thereby providing a suitable replacement for 2D and 1D barcodes for monitoring units in cartons or on pallets.
 
The integrated approach presented to the Board of Pharmacy overcomes the limitations of 1D and 2D barcodes, which are static and cannot be updated as products move through distribution. The presenters showed that Battery Assisted Passive RFID tags, in conjunction with cloud-based software-as-a-service traceability solutions and intelligent returnable transport items (such as RFID-equipped plastic containers and pallets) can securely record the chain of custody data and any changes of content data at any point in the distribution cycle. This approach can aid in anti-counterfeiting and reduces the diversion of high-value drugs and temperature-sensitive biologics. It also provides an efficient method of high-quality data capture and content monitoring with the flexibility to meet changes to regulations and application upgrades.
 
“The real value for the e-Pedigree investments being made will not only increase consumer confidence, but at the same time reduce the time and cost for recovery,” said Ann Grackin, CEO of ChainLink Research. “Companies can leverage investments in RFID, track-and-trace applications and returnable transport items to provide real-time responsive supply chain management. This information can address a variety of benefits from better inventory position, cost containment, and product locating to assure customer service, safe product dispensing, to name a few.”  
 
The presenters noted that data can be stored securely on Battery Assisted Passive tags to provide a chain-of-custody record (an RFID e-Pedigree) and a record of the aggregated individual unit serial numbers – all within the tag's memory securely to further enhance their usability in this environment.  The same approach ensures that, even at the last point of the distribution chain, the authenticity of the product can be validated by reading the tag and matching its contents with those of the product’s manifest. The presenters also showed that Battery-assisted Passive RFID tags can wirelessly monitor the temperature and condition of products inside cartons or containers – without requiring unpacking of their contents – to help reduce temperature excursions (variances), while ensuring the security and authenticity of the products inside the package.
 
“Providing pharmaceutical manufacturers with a method to serialize with random unique identifiers efficiently and track product easily is essential to building a secure supply chain,” said Kevin Erdman, President of Verify Brand.  “Additionally, enabling product authentication throughout the supply chain via mobile and Web applications increases manufacturers ROI from serialization efforts while meeting regulatory compliance and mitigating risk of counterfeit product from entering the supply chain.”
 
“Using a solution that leverages the value of Intelligent Reusables that already exist in the pharmaceutical supply chain only makes sense,” said Kaley Parkinson, National Sales Manager at Rehrig Pacific. “Reinventing a different, secondary alternative solution only adds cost and barriers to the rapidly approaching implementation deadline. Pairing a regulatory solution with a safer way to get medicines and biologics through the supply chain lowers implementation costs and improves patient safety at the same time.”
 
“New e-Pedigree regulations  will require pharmaceutical manufacturers, distributors and logistics providers to redefine their cold supply chains, and traceability processes, said Peter Mehring, President and CEO of Intelleflex. “SaaS-based solutions, intelligent RTIs with embedded temperature monitors, and cloud-based data services like ZEST, will enable the cold chain to proactively address the new cold chain dynamics for serialization and potentially provide a solution for inference adoption.”
 
A video of the presentation can be found at: http://www.youtube.com/watch?v=064DdbZvnZw

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