Countdown to November 27: Six Milestones That Should Be Behind You

The end of May marked the start of the six-month countdown to the DSCSA serialization deadline for manufacturers. Beginning November 27, manufacturers must sell only serialized product. 

Any company that is already serializing, or is well on its way, knows that preparations are inevitably more involved than initially anticipated. If your pharma company is subject to the November deadline but has not yet begun serializing product, how do you know whether you’re on track to make it?

Based on working with hundreds of DSCSA customers to prepare, we’ve compiled a list of milestones that should be far behind you at this late date. Hopefully, with the guidance of your solution partner, your company has already checked all of these off your list. If you haven’t, that’s a strong indicator that you may not be ready in time.

1. Master data: Details are in order

In order to legally serialize products, companies have master data prep work to complete. You need to have product information such as National Drug Codes and product descriptions at hand, and you also must have a Global Trade Item Number, or GTIN, for each packaging level.

For serialization data, you’ll need a Global Location Number, or GLN. The GLN is also part of your partner master data, which is used by trading partners. Some data elements will need to be registered with GS1, which doesn’t take a lot of time, but by now you should have crossed these items off your list.

2. Serial number generation: Responsibilities are assigned

Most pharmaceutical companies choose to generate the serial numbers for their own products, but some ask their CMOs to do it on their behalf. Yet another group pursues a hybrid model, generating numbers for products they manufacture internally, but tasking their CMOs with generating numbers for the products they produce externally. There is no right answer, but by now, you should have evaluated the pros and cons of each option, come to a decision, and communicated it to all of your CMOs.

3. Serial number format: Decisions are made

DSCSA specifies certain GS1 guidelines for serial number format, but it does not mandate the exact details. Because of that, you have options—and choices to make. These include the length of your serial numbers, or the length of the number added to your serial number, such as a GTIN.

In addition, you also need to address some formatting issues. Will your serial numbers be alphanumeric or numeric only? Will you generate them sequentially or randomly? Again, there is no right answer, but conversations need to be had around which options are best for your company.

4. CMO onboarding: A schedule is in place

For this year’s phase of DSCSA, where pharma companies must serialize product but do not yet need to send that data to downstream customers, the most critical collaboration is between you and your CMOs. Every CMO must be onboarded so that you can seamlessly send serial number data back and forth. If that connectivity isn’t in place, you can no longer rely on these partners to get your product out the door.

Any pharma company who’s completed this process with even one CMO will tell you that it’s complicated. Ask them how long it took to connect with just one partner, and the answer could be as long as six months. At this stage in the game, you need a schedule for which partner will be onboarded when—and a network model that greatly streamlines the entire process.

5. Artwork: Revisions are complete

A key part of serialization is redesigning your product labels to accommodate the 2D DataMatrix code. Because many packages are small, it’s actually a big task to redo the artwork. If the packaging isn’t big enough, font size—and sometimes even the packaging itself—may need to change. Before you can move to production, your new artwork needs to be in place.

6. Test runs: Complete, or on the calendar

Prior to the deadline, your pharma company will need to complete a test run with every CMO partner to ensure that you can successfully send serial numbers to them, and that they can report back. You will want to test all of your internal lines as well. While you don’t need to be done with all those test runs at this point, you should have a schedule of which test will take place when so you’re confident you can fit them in before November 27 arrives.

All of this assumes that your new line equipment is in place. If your company—like many others—is still waiting for the hardware to arrive, your timeframe will be even tighter, and it will be even more important that your solution provider has out-of-the-box integrations with your LMS of choice, and experience integrating with them.