By Kevin Swartz and Tina Gushue, IPS-Integrated Project Services
A reminder to pharma manufacturers, the Drug Supply Chain Security Act (DSCSA) deadlines are quickly approaching. Have you planned for the implementation of Transaction Documents for your packaged products and how to introduce them into your supply chain? Have you developed a strategy for implementing packaging serialized data and infrastructure?
With the coming New Year, the Drug Supply Chain Security Act (DSCSA) requires Transaction Information, Transaction History and a Transaction Statement be forwarded to your distributors with the finished packaged product. Most wholesalers have specific requirements for how to do this. Have you spoken with them? Do the right people in your organization know the requirements?
We’re only a few months out. Documents should be going through your quality departments and vetted out with dry runs to ensure you’re not only compliant, but well versed in the process.
Once you’ve got the Transaction Documents squared away, it’s time to create a strategy to implement serialization into your packaging lines by November 2017. This may seem far away; however don’t underestimate the amount of time required to develop and execute a solid, well-thought plan. There are many steps that need to be taken before these systems can go live.
First, put together an internal team that understands your corporate culture and processes to learn about the requirements for DSCSA compliance. Then, contact and interview serialization solution vendors. These include machine level printing and vision up through line control, plant data management and enterprise systems to communicate with your ERP system. Once you’ve got a solid understanding of vendor requirements for time and cost, put together your budget and capital requests quickly. As you know, the approval phase of these budgets takes time (sometimes significant time) away from your implementation and troubleshooting. Also note that it’s critical to pick the right partner-vendors. Remember thousands of other companies are speaking with those vendors too. As the deadline approaches, your first choice(s) may have lead times that exceed your timeline and costs that exceed your budget.
As you learn more about what is required from a compliance level and from a resource and education level, you may decide that 100% internal resources for the project are not available. We all have other daily responsibilities.
Now that you’ve been reminded, let’s get started!
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