By now, the Drug Supply Chain Security Act (DSCSA) is familiar to all U.S. pharmaceutical manufacturers.
The regulation challenges the industry, requiring alterations to existing production lines and management of big data. Through the year 2023, a series of deadlines call for product and package marking. They also demand the transfer of serialization information through the pharmaceutical supply chain.
Recently, the FDA announced draft guidance for pharmaceutical manufacturers. It recommends a delay of the enforcement of DSCSA product identifier requirements. While the November 27, 2017 deadline has not officially changed, a one-year grace period exists before receiving penalties 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.
The Challenges Ahead
Although manufacturers 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. More challenging, manufacturers need to accurately manage the vast data these new requirements will generate.
So, is the minimum requirement of unit serialization a wise path for your business? In the real world, manufacturers need to prepare 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. These solutions should not disrupt production or distribution when the next deadline approaches.
We call this approach smart serialization.
Smart Serialization with Pharmaceutical Track and Trace
One important characteristic of smart serialization in pharmaceutical track and trace is creation and capture of fully aggregated data. This makes sharing information easy and valuable for the entire supply chain. Manufacturers need to capture single unit serialization data, but can also provide bundle, carton and pallet aggregation information to distributors.
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 the right solution can easily accomplish the task.
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 appear 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 pharmaceutical 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 with pharmaceutical track and trace.