Issue link: https://www.e-digitaleditions.com/i/276262
34 March 2014 Tablets & Capsules To implement the newly defined structures, managers must deploy interdisciplinary project teams and give them company-wide access. These teams must implement the standards and thereby ensure that all relevant infor- mation flows freely. This includes supplying a product's proof of origin—from the manufacturer through distribu- tion to patients—as well as the date, invoice number, and expiration date of each transaction. Sourcing When applying their implementation strategy, phar- maceutical companies must select qualified partners to put their serialization program into action. Currently, only a few suppliers offer end-to-end track-and-trace sys- tems that meet all international requirements. For this reason, managers should evaluate and select suppliers at an early stage and give special consideration to • Current information. Is the supplier knowledgeable about the applicable legal requirements in the coun- tries concerned, and does it coordinate its products and services accordingly? • Integration expertise. Does the supplier apply solu- tions with tried and tested components and inter- faces? Does the supplier provide support for system integration? • Performance. Are the supplier's solutions flexible enough to form tailored connections to existing sys- tems and can they support an international rollout? • Service efficiency. Is the partner's support network developed internationally and strategically, allowing for quick on-site service? Seek systems with a modular design to simplify integration with a variety of production lines. sectors—and the information technology (IT), certifica- tion, and validation departments in particular—are affected on a much greater scale. Issuing serial numbers obtained dynamically from an enterprise-resource plan- ning (ERP) system (with subsequent feedback to a central database) is a must for serialization, and that requires a close connection to the company's IT infrastructure. Increased complexity requires a strategic approach Since tracking measures don't stop at the factory gate anymore, pharmaceutical companies have a greater duty now to monitor and document all aggregation levels throughout the supply chain, from production to distrib- ution. These tasks often reach an international scale, which means that product marking must be addressed company-wide. For international pharmaceutical companies, each new market entered brings an additional challenge as there are more and more country- and region-specific regulations pertaining to declaration and traceability. This compli- cates companies' conversions to a track-and-trace system that includes serialization and aggregation. In developing a strategy for a track-and-trace system that is secure, seamless, and provides interdepartmental data flow to ensure the organizational structures are ready for the future—take into account five factors: comprehensiveness, structure, sourcing, interoperability, and efficiency. Comprehensiveness Pharmaceutical manufacturers operate their facilities in multiple countries and across continents. Making their products traceable thus demands serialization solutions that meet all country-specific requirements while simulta- neously maintaining a uniform product structure. During conversion, take care that you and your team don't over- look a manufacturing stage or a distribution method. Only a complete serialization program can monitor prod- ucts from the manufacturer all the way to the patient. Implementing a far-reaching track-and-trace project com- pany-wide should • Define track-and-trace as a management task; • Integrate the data flow and specialty departments throughout the value-added chain; • Determine an in-depth data flow model for the com- pany; and • Customize certification and validation processes as necessary. Structure All companies, but especially those with global reach, will benefit from standardizing their in-place processes early. For many companies, the first step is to evaluate, extend, and document existing in-house standards. By so doing, companies can identify and eliminate any stand- alone operations that remain, allowing all track-and-trace lines to be adapted to the new specifications. i-Pabschart_33-35_Masters 3/5/14 10:14 AM Page 34