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Jennifer Markarian is manufacturing editor of Pharmaceutical Technology.
Upcoming requirements in the US and around the world for serialization and track and trace of pharmaceuticals were a focus of the Pharmapack conference held in Philadelphia, PA earlier this week.
Upcoming requirements in the US and around the world for serialization and track and trace of pharmaceuticals were a focus of the Pharmapack conference held in Philadelphia, PA earlier this week. Momentum toward implementing these technologies across packaging lines is building as deadlines, including California’s requirements in 2015 and others around the world, approach. After listening to several presentations and a panel discussion, the message I heard loud and clear was that time is of the essence and that packagers should prepare for serialization now.
Some companies have delayed working on serialization because US federal track-and-trace legislation is not yet in place, although a vote could come this summer. Regulations in California and other countries, however, are approaching deadlines for implementation. Many companies are moving forward despite federal delays, said panelists.
Others may have delayed programs because of the lack of harmony in requirements from various countries. Packagers should not wait for globally harmonized standards, however, before deciding what to implement, warned Peter Schmitt, managing associate at Montesino, in his presentation, “Finding a common denominator in the (dis)harmonized global serialization standards.” He suggested that, instead, companies should adopt flexible labeling, printing, and vision systems that can be adapted for different regulations in different countries. Regulations are a work in progress and might still change, but he advocated setting up a scalable and configurable (rather than customized) serialization system now and being prepared to grow it quickly. Requirements for such a system would include high resolution and high bandwidth to handle large amounts of data.
Panelists pointed out that benefits of serialization go beyond complying with regulations. One of these benefits is the hidden business opportunity to take logistics to the next level. Pharmaceutical companies could gain the benefits found by other industries, such as consumer electronics, automotive, and apparel, that implemented unit-level serialization long ago. For example, serialization could improve supply-chain collaboration on processes such as returns. Schmitt pointed out that the data obtained by serialization systems can be mined to find patterns in the packaging process, which would allow problem solving as well as potentially lowering packaging cost and aiding new packaging development. Panelists agreed, however, that the biggest benefit, which should also be the biggest driver for use, is the increased patient safety that would result from improved supply-chain integrity and security. “Does patient safety need a business case?” someone asked.
For further commentary on the pending US federal track-and-trace legislation, read an article in the June issue of Pharmaceutical Technology by PharmTech’s Washington Editor, Jill Weschler, “Congress Considers Legislation to Secure Drug Supply Chain”.