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Pharmaceutical & Medical Packaging News, November/December 2015

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17 November/December 2015 Pharmaceutical & Medical Packaging News • pmpnews.com will clearly be funded by your brand. But if you outsource some production or represent a contract partner, the question of financial arrangements is a big one. Upgrades may cost between $250,000 and $500,000 per line. Who should pay? Many contract partners will be looking for pharmaceutical compa- ny support—especially for dedicated lines—but pharma companies will have their own opinions about wheth- er to contribute at all or how to split financial responsibility with both the contract firms and their other phar- ma customers. There is no established commercial model for this, so each partnership will require negotiations. Downtime. You can't upgrade lines without incurring downtime. How long will each upgrade take? Adjust production schedules to ensure that you have enough stock of what- ever products depend on those lines to get you through the process. Artwork. While design changes aren't strictly part of line upgrades, they are one more consideration dur- ing this process. Many pharmaceuti- cal companies are finding that label changes are required in order to make room for the 2-D bar codes and any human-readable components. When that's the case, time must be built-in for both the redesign work and the FDA approval of the revised layout. Trade ParTner coMMUnicaTion Physically serializing product is just one half of the challenge. The other half—trade partner communications—is arguably the more-daunting endeavor. Connections. The U.S. regula- tions mandate that supply-chain com- panies perform some combination of generating, tracking, exchanging, and storing serialized information. How will your pharma company send the serial numbers you've created to the contract partners that are packag- ing your product? And as a CMO, how will you communicate back seri- alization events—reserved, commis- sioned, decommissioned, destroyed, and more—that occur at your facilities and may need to be tracked in order to ensure the integrity of the serialization data? You will need to electronically inte- grate with each pharma or CMO part- ner. Traditional technology supports this via individual, custom point-to- point connections. But there is a high cost and level of effort associated— particularly since evolving regulations necessitate frequent changes—and each one takes approximately 9 months to establish. If you're targeting the November 2017 DSCSA serial- ization deadline, you really only have 18 months left, because most phar- ma companies are going to want a 6-month bufer to allow for unantic- ipated complications and to ensure their product is ready in time. Is 18 months enough time to tackle each of these connections, plus attend to all your other preparations? Variable demands. If you pro- vide contracted manufacturing and packaging services, you likely serve numerous pharmaceutical customers. Because each of them has a unique set of internal systems, each of them will have unique and complex inte- gration demands around mapping, event choreography, transmission pro- tocols, validation, and more. Collect- ing, understanding, and implementing these demands from clients who have no intention of following any sort of standard will add untold time and efort to your process. MUlTiPle ParTners MUlTiPly The coMPlexiTy In many regards, working with multiple partners will complicate seri- alization for both pharmaceutical com- panies and their contract partners. CMOs, you are at risk for being inun- dated by pharma company requests all at the same time, and potentially at the last minute. Pharma companies, you are balancing internal and external production plans and can't aford to prioritize one behind the other, or you won't have serialized product in time. There are two key steps you can take to expedite your progress and simplify the overall process: Start conversations now. If you haven't already had a detailed require- ments conversation with each pharma or contract partner, get the ball rolling. Use a checklist for pharma companies or contract partners to help guide the discussions. Simplify your approach. Seri- alization in today's global supply net- work is inherently a network data exchange problem, which means relying on traditional technology for partner communications will be a painful—and potentially untenable— option. Look toward new technologies for a shared platform or network data exchange solution that would reduce individual connections and mitigate unique partner demands. 0 Graham Clark manages CMO/CPO Partnerships at TraceLink, a company focused on helping pharmaceutical manufacturers, dis- tributors, and dispensers deliver safe prescrip- tion medicines to patients everywhere with the largest track-and-trace network in the life sciences industry. Clark collaborates with the global CMO community to ensure that they are ready to support their customers' serializa- tion requirements. He also works with major pharmaceutical brands to implement CMO serialization programs. If you are targeting the November 2017 DSCSA serialization deadline, you really only have 18 months left, because most pharma companies are going to want a 6-month buffer.

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