Prepare Now For ePedigree Compliance New technology offers building blocks for full-line solutions in wake of troubled economy, regulation delays

Fri, 11/13/2009 - 4:39am
By Bob Neagle Business Unit Manager, Brand Protection Solutions Videojet Technologies Inc. More stringent regulations regarding electronic pedigrees, or ePedigrees, are coming. However, compliance deadlines are fluctuating, and the industry continues to buzz about new approaches to legislation. Plus, with today’s economy in flux, many pharmaceutical manufacturers are reluctant to make a capital outlay for a complete mass serialization system just yet. New systems are available that enable pharmaceutical manufacturers to begin building an ePedigree-compliant packaging line, offering expanded traceability and inspection benefits to work toward implementing full-line solutions that meet future regulations. Furthermore, these solutions can help pharmaceutical companies protect their valuable brands today. Economy, compliance delays create challenges In today’s economic environment, many pharmaceutical companies are reluctant to invest in a full-line mass serialization system, especially with the California ePedigree compliance deadline delayed to 2015. However, new components are available for systems that enable pharmaceutical companies to begin building an ePedigree-compliant packaging line system to achieve greater capabilities now and install a full track-and-trace solution in the future. The ability to install components of a track-and-trace solution helps pharmaceutical manufacturers space out the purchasing for all the components of a complete system and avoid making a large capital payment. Plus, manufacturers that enhance their line can realize benefits that may offer some cost savings on the production line and expanded capabilities. For example, the IMprints™ CodeMatch machine vision inspection system from Videojet Technologies Inc. provides a wide range of inspection tools for validation and verification of label information. These tools provide capabilities to ensure code quality and can be built upon to later create a full track-and-trace solution. Solutions like this enable pharmaceutical companies to verify that the product label has the correct information and that the correct label has been placed on the packaging with a valid serial number for traceability. Track-and-trace solutions are designed to create a mechanism for applying unique codes to primary packaging on the production line and tying those codes to intended destinations to create a supply chain history. While track-and-trace systems create a supply chain history for an individual product, they also form “parent/child” relationships to capture shipping aggregations, such as case and pallet packaging. This enables manufacturers to review a history of shipping details through a hierarchy to determine the pallet on which an individual product and case were transported. The ability to capture this level of data benefits pharmaceutical manufacturers and their brands, especially in a challenging economy in which reducing unnecessary costs is essential. Protecting brands protects revenue against counterfeit products, dilution of brand image among consumers, negative public opinion and disruption of business to respond to a recall. Beginning with a validation and verification system that can later be built into a complete traceability solution can help pharmaceutical companies achieve some cost savings today. The validation system can reduce the need to recode inaccurate, unclear or invalid unique identification codes. Plus, the system ensures the information required for supply chain traceability is present and accurate. Managing the supply chain Before 2000, variable data coders essentially just provided the ability to manage product by lots or batches. This meant that if the manufacturer needed to recall a product, that recall would affect an entire batch — even if the entire batch wasn’t compromised. As a result, manufacturers incurred significant costs to perform the recall, not to mention the damage sustained by the brand due to negative publicity. But today, marking and coding technologies offer the ability to manage the product at the item level. Thus, if there is a concern that a product may have been tampered with, a manufacturer doesn’t recall an entire batch, but instead informs specific stores directly about the recalled product. In this way, the problematic product can be targeted and removed from the supply chain, meeting traceability requirements, and reducing cost and negative publicity, while also possibly saving consumers’ lives. As an added benefit, through random checks of the supply chain and retail locations, product manufacturers can quickly identify counterfeits or items obtained through diversionary means. Examining the different types of overt and covert codes on a package and the data contained within them can quickly determine whether the products on a distributor or retail shelf are authentic and belong there. Plus, inspectors can view the authorized supply chain history, tracing the product back to the last member of the supply chain to handle the unit and confirm at what point the product was diverted from its intended supply chain. Brand protection solutions One important method of protection is through the use of variable data marking and coding on primary and secondary packaging. Technologies can include ink jet printers, laser coders, thermal transfer overprinters or a combination of technologies that provide multiple layers of protection, thus making it more difficult to counterfeit or divert products. As marking and coding technologies evolve, manufacturers are seeking solutions that are unique to their packaging to make counterfeiting and diverting products more difficult while satisfying track-and-trace requirements. They are looking for truly unique codes that use custom inks, fonts and identification codes. One of a pharmaceutical manufacturer’s most important assets is its brand. Consumers are willing to pay a premium price for brands they trust, and that translates to both profit and marketplace power. But brands face many threats, and like any asset, they need to be protected. Criminal enterprises can steal a portion of the investment in a brand for themselves by counterfeiting or unlawfully distributing pharmaceutical products, a tactic known as diversion. Counterfeiters also can engage in product terrorism by hurting consumers who purchase a product, thus damaging a brand’s equity and the manufacturer. Combining marking and coding technologies with software that generates unique, random codes that are placed directly on a package will go a long way in protecting the brand, the manufacturer and the consumer. Plus, this same software generates the unique codes that can be used for traceability. Maximizing success To maximize the potential for success, solutions must be tailored to the unique needs of a pharmaceutical manufacturer’s brands. Components of a brand protection solution and ePedigree-compliant packaging line can include: * Digital license plates: Digital license plates validate manufacturing origin and product quality by integrating item-specific data into a unique code format, such as a pseudo-random code. The carrier for these license plates can range from human-readable characters to a 2D bar code, and the information contained within the code provide ePedigree-related supply chain data. * Proprietary algorithms: Proprietary algorithms enable manufacturers to create “intelligent” codes embedded with unique item-level properties, simplifying data mining downstream. * In-line verification and compliance: The need to verify code accuracy and repeatability is vitally important in brand protection efforts, so a manufacturer knows (and can verify) what codes have entered the supply chain. Often this requires high-quality results printed at high production line speeds, a difficult feat for ink jet printers 10 years ago. * Production line controls: Production line controls are often required to create parent/child relationships by tracking items into shipping cartons and shipping cartons into cases. Production line controls actually monitor each item as part of the production flow and keep accurate counts while assigning unique identifiers in the process. If required, the controls can interface with in-line vision systems to validate code accuracy or to read and print downstream. Implications for the future Beginning implementation of ePedigree-compliant packaging lines today is an important, proactive step in meeting upcoming ePedigree legislation. Plus, installing components today can help ensure brand equity — and consumers — are safe from counterfeiting and diversion threats. Beginning to implement an ePedigree solution can seem daunting, especially in the current economy, but investing in available components can make installing the full line a more efficient and cost-effective process in the future. About the author: Bob Neagle is business unit manager of Videojet Technologies’ Brand Protection Solutions group. The Videojet Brand Protection Solutions group incorporates variable data marking and coding solutions with data management to provide robust and customizable track-and-trace solutions tailored to the specific needs of customers. Neagle has worked for Videojet for four years, and prior to his current position, he was senior manager for graphics systems for Videojet, which is headquartered in Wood Dale, Ill. He has a bachelor’s degree in management from the University of Illinois-Chicago.

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