PMPN_Pharmaceutical & Medical Packaging News

Pharmaceutical & Medical Packaging News, November/December 2015

Issue link: http://dc.cn.ubm-us.com/i/609216

Contents of this Issue

Navigation

Page 15 of 35

SupplyChain pmpnews.com • Pharmaceutical & Medical Packaging News November/December 2015 16 Serialization: Why Manufacturers and Packagers Must Prepare Now It is time for pharmaceutical companies and their supply-chain partners— including their contract manufacturing and packaging partners—to establish all expectations for serialization projects. by Graham Clark TraceLink I n response to increasing drug integrity concerns, more than 40 countries have introduced track- and-trace laws to help regulate prod- uct as it passes through the supply chain. By 2019, more than 75% of the world's prescription medications will be protected by legislation. While no two countries have p a s s e d t h e e x a c t same requirements, they all rely on one c o r e c o m p o n e n t : serialization. Seri- a l i z i n g p r o d u c t — a s s i g n i n g u n i q u e , traceable numbers to individual sale- able units—is the cornerstone of all the regulations. Serialization is a complex process that will have a ripple efect through- out operations at both pharmaceutical companies and their contract manu- facturing and packaging partners. The process of implementing serial- ization in your company—whether you represent a pharma company or an outsourced partner—goes far beyond creating a number and afx- ing it to the side of a package. Seri- alization introduces a paradigm shift for the industry. As a manufacturer, your company has been focused on producing identical units to an exact- ing standard. With serialization, the focus evolves to producing that same product, identifying each item with unique data, communicating that data to supply chain partners, and then— depending on your supply-chain role—potentially accounting for that data for several years to come. When and how do you begin to pre- pare? This article will help you with the "how" by discussing considerations and first steps for both pharmaceuti- cal companies that are manufacturing their own product and for external partners that are packaging on their customers' behalf. And in reviewing that, the "when" will become read- ily apparent: as you map out the dates by which you'll be required to deliver serialized product and then work back- wards, taking all necessary steps into consideration, you will realize that the time to start is now. Two Major ProjecTs, Many cascading challenges In order to produce product in a serialized world, two major projects must be addressed: lines upgrades and trade partner integrations. Let's con- sider what's involved with each, what additional questions they raise, and where to get started. line UPgrades Serializing product requires upgrad- ed packaging lines, and those upgrades involve their own set of challenges and decisions, including: Equipment. You will need to determine new equipment needs. Will your current printers, for instance, be able to produce the required 2-D bar codes? And are your vision systems up to the challenge? Line system ven- dors are predicting that as the entire industry prepares for serialization, order fulfillment times will balloon to several times their usual length, so fac- tor in lead time. Specifications. You will want to understand your company's or cus- tomer's exact requirements. How many lines, for instance, will be expected to support aggregation? That alone will impact the set up and signifi- cantly increase the cost. Commercial responsibility. If your pharma company manages all production internally, line upgrades Graham Clark, Tracelink The process of implementing serialization in your company—whether you represent a pharma company or an outsourced partner—goes far beyond creating a number and affxing it to a package.

Articles in this issue

Links on this page

Archives of this issue

view archives of PMPN_Pharmaceutical & Medical Packaging News - Pharmaceutical & Medical Packaging News, November/December 2015