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Pharmaceutical & Medical Packaging News, November/December 2014

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SupplyChain pmpnews.com • Pharmaceutical & Medical Packaging News November/December 2014 16 Just-In-Time Color Labeling in a Changing Supply Chain Flexibility, accuracy, and effciency in labeling are necessary to support changes in pharmaceutical and medical device regulation and demand. By Kelly Ng, Product Manager Epson Healthcare T rends in labeling regulations are disrupting the pharmaceutical sup- ply chain. The Drug Quality and Security Act (DQSA) implementation guidelines expected shortly are adding uncertainty to label formatting and data management. Added label complexities in terms of dosage, branding, and warn- ings further compound the situation. And with clinical trial labeling, each label must be reviewed and approved by com- pany and regulatory ofcials. As a result, the high frequency of clinical trials means that labels are in constant flux—placing added pressure on the production team. In order to properly implement these new standards along the supply chain and remain com- petitive, manufac- turers are turning to flexible tech- nologies. As the need for efciency, variability, and scalability along the supply chain continues to grow, on-demand color technologies play increasingly important roles in pharma- ceutical packaging operations. The industry has witnessed a rise in smaller batch sizes and in high-value, spe- cialty drug manufacturing. This size order reduction is fueled by tighter inventory management and increased demand for specially formulated, low-volume drugs. Specialization or personalization for smaller batch runs—particularly for spe- cialty drugs that are privately branded— are recent trends that reflect consumer demand, which will con- tinue to grow in the market at a steady rate. Ultimate- ly, more compounding and specialty production is taking place as industry changes lead to further deviation from standard dosage productions. Dispensing locations, however, cannot predict the amount of low-volume drugs needed for distribu- tion—new patient require- ments remain difficult to forecast. To avoid wasted inventory costs, these loca- tions are now keeping mini- mal quantities on hand. A streamlined production pro- cess, with new methods and technologies that can han- dle a plethora of labels with changing logos, drug information, and warnings, is required to deal with shifts in batch label production. And a fast turn- around is needed to maintain nimble production and better serve customers. In medical device production, many devices are custom fitted to a patient. Devices can look similar, but one small change means that the device is custom- ized for an entirely diferent procedure. Specifically for medical devices, FDA approves the application of labels and related regulations—maintaining a con- sistency in constantly changing labels. Getting timely changes and delivery of medical device labels is a demanding job. With increased customization, lot sizes are smaller, which means that label runs are smaller. Medical devices have a simi- lar production and dispensing process as specialty drugs and are also subject to frequent small, customized batches. Flexible printing options to accommo- date the coding, marking, and labeling of short-run products are available to manu- facturers in the form of ink-jet on-demand technologies. These printing technologies allow manufacturers and distributors to tackle variability and provide value-added services (e.g., private branding or clinical trials) while retaining flexibility to quickly changeover between product batches and to scale up production. As generic medications become even Kelly Ng, Epson Epson's Just In Time ColorWorks technology and JITC labeling solutions were developed to help operators adjust to industry trends. Epson's digital ink-jet printers offer scalability to allow distributors to efficiently grow in capacity, without compromising the quality and labeling accuracy of the production process. For more details, visit www.epson.com/pharma (Contact Us) or connect with Epson America Business Systems Division on Facebook (http:// tinyurl.com/EpsonFacebook-BizSys), Twitter (http://twitter. com/EpsonB2B_PR) and YouTube (http://tinyURL.com/ EpsonYouTube).

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