A group of packaging solution providers have come together to provide a single team that can help drug companies prepare for upcoming electronic pedigree and serialization requirements.
In September, Peter Schmitt, founder of Montesino Associates, provided an update on Brazil’s law requiring serialization for pharmaceuticals in the live Webcast, “Update: Brazil Law 11.903—An “Emerging” Regulation for Traceability & Serialization.” The law and the original ANVISA guidelines detailed a program of serialized code in 2-D Data Matrix format on a security label printed by the national mint that was to be rolled out in June 2010.
A joint collaborative between Acsis Inc., Cognex Corporation, Nosco, and Omega Design called “4 Serialization" is designed to help manufacturers, wholesale distributors and contract producers within the pharmaceutical and bio-tech industries implement product serialization and visibility throughout the supply chain to ensure patient safety and prevent counterfeiting. The ability to integrate a solution that is flexible enough to accommodate serialized and non-serialized products during a phased rollout can seem daunting to any organization.
In June, several products suspected of being counterfeit or unauthorized were seized or obtained by regulators. The Medicines and Healthcare products Regulatory Agency reported the seizure of counterfeit and unlicensed medicines such as painkillers, sedatives, and steroids in London. FDA reported it was able to purchase “generic Tamiflu” over the Internet, even though the agency has not yet approved a generic version of the drug.
RedPrairie Corp. has announced that OM HealthCare Logistics, a new business unit of Owens & Minor, has adopted RedPrairie’s Warehouse Management solution to handle its third-party logistics distribution center operations. OM HealthCare Logistics is using the system for medical device and pharmaceutical distribution and management and will also use the system for kitting and serialization track and trace for its clients in the future.
The healthcare supply chain may be getting safer. Surprisingly, the recent strides that have been made have been in removing suspect products from Internet auction sites.
LeadsOnline is an online database system that houses serial codes and other identifying numbers of products on sale at businesses such as second-hand stores, Internet drop-off stores, and others across all 50 states. For instance, LeadsOnline is an official partner of eBay.
Pharmorx Security’s (Southborough, MA) name change to Covectra is part of a larger mission to address new and existing clients’ requirements for secure and comprehensive brand protection solutions. By combining covert and overt security features printed on products and packaging materials with the AuthentiTrack software platform, Covectra provides a complete portfolio of products and services to protect and enhance a product brand.
Verify Brand (Minneapolis) has released VB Enterprise 2.0, a suite of Web-based, configurable software applications for fighting counterfeiting, grey market diversion, warranty and return fraud, and theft. It also aims to ease handling of recalls, manufacturing overruns, and brand promotion. The patent-pending platform manages the life cycle of unique product identification by increasing supply-chain visibility.
To prepare for serialization within the U.S. pharmaceutical supply chain, GS1 Healthcare U.S. is launching The 2015 Readiness Program. Intended to provide an industry reference model using GS1 standards, the program allows participants to simulate supply-chain activities employing serialization.
D. Bruce Cohen, an industry leader in pharmaceutical packaging for more than 35 years, is now owner and principal of PackTechPlus LLC. Cohen has held positions at Alcon Laboratories, BBL, Boehringer Mannheim Diagnostics, Sterling Drug Inc., Glaxo Inc., and GlaxoSmithKline.