By now, the Drug Supply Chain Security Act (DSCSA) is familiar to all U.S. pharmaceutical manufacturers.
The regulation is a huge challenge to the industry that requires alterations to their existing production lines and management of vast amounts of new data. Through the year 2023, there is an ongoing series of deadlines which calls for product and package marking, as well as transfer of as transfer of serialization information through the pharmaceutical supply chain.
Recently, the FDA announced draft guidance for pharmaceutical manufacturers which recommends a delay of the enforcement of DSCSA product identifier requirements. While the November 27, 2017 deadline has not officially been changed – there is now a one year grace period before penalties are applied for non-compliance. However, manufacturers are still subject to the minimum requirement of attaching or imprinting a globally unique product identifier on every saleable unit that will enter commerce. This Global Trade Identifier Number, called a GTIN, must is created in accordance with GS1 standards and contains information about the product manufacturer, creation date, and package quantity.
Although manufacturers may have extra time before enforcement begins, it’s important to remember that the requirements and deadlines for the rest of the pharmaceutical supply chain remain unchanged. Perhaps more important, and even more challenging for manufacturers will be the need to effectively and accurately manage the large amounts of corresponding data these new track and trace requirements will generate.
So, is the minimum requirement of unit serialization a wise path for your business? In the real world, manufacturers need to be prepared to coordinate and share data with distributors when their respective serialization deadlines arrive. Given this extra time, manufacturers can design the best solutions for both their lines and supply chain, without disrupting production or distribution when the next deadline approaches.
We call this approach smart serialization.
One important characteristic of smart serialization is creation and capture of fully aggregated data to make the sharing of information easy and valuable for the rest of the supply chain. This means that manufacturers need to capture single unit serialization data, but also can provide bundle, carton and pallet aggregation information to distributors as needed.
Flexibility is also important aspect of smart serialization. Some manufacturers need the flexibility to run Rx and OTC products on the same line. This requires an additional level of planning and control, but can easily be accomplished with the right solution.
Another key feature of smart serialization is the ability to keep data in-house until the corresponding product is transferred. Maintaining control of the data minimizes data transfer time during packaging and palletizing, and it also maintains flexibility as data exchange and reporting standards evolve.
And of course, once manufacturers can monitor their data, valuable insights can be gained from the production line data. Analyzing this data is key to improving quality metrics, materials management and production optimization.
Taking a holistic view of serialization and track and trace technologies will focus your resources and help avoid costly changes and additions to your production lines later.
Watch this video on Smart Serialization.