Are You Ready to Exchange Serialization Master Data?

Watch this Take Five video to learn how with limited time left to onboard, experts urge pharmaceutical manufacturers to begin testing and sharing traceability data with distributors ASAP to meet DSCSA requirements.


Quick hits:

  • Distributors discuss the benefits of using EPCIS files for sharing DSCSA traceability data.
  • Not much time is left to onboard and debug data sharing operations.
  • Exception management is critical. Product can and will pile up at the dock or be quarantined if distributors don’t have serialization data to receive it against. 

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   Read the transcript below:

I’m Keren Sookne with Take Five Video with Healthcare Packaging.

Today we’re talking about the rapidly approaching Drug Supply Chain Security Act requirements, and how companies are learning to exchange master data with their trading partners.

Now first, let me be real. This is a 5-minute video and this is a massive topic, so I’ll link to a couple intro materials below if you’re not familiar with serialization and DSCSA. 

A major component of this legislation is the practice of assigning a unique serial number linked to product data to each salable unit of prescription drug products. Drug manufacturers must share this data with downstream trading partners so they know it is legitimate as it moves through the supply chain. 

This may sound easy but when you think about the complex web of distributors, 3PLs and manufacturers all sharing data on millions of products in real-time… it’s quite a challenge. 

At HDA’s Traceability Webinar series, experts held a discussion on master data exchange—the good, the bad, and the ugly.

At present, the exchange of master data is a manual process. Serialization data is manually pulled from internal systems, and spreadsheets are maintained and emailed back and forth to trading partners.

How can this exchange become automated? Panelists said the answer lies in manufacturers using a common framework to exchange data: EPCIS files which stands for Electronic Product Code Information Services.

EPCIS is a global GS1 Standard for creating and sharing visibility event data, both within and across enterprises, so that users gain a shared view.

So let’s say you’re a manufacturer and you want to start sending EPCIS files to your distributors. A “happy path” best case scenario for the onboarding process can take 6 weeks with exchanging data, testing and moving to production.

Now if every distributor needs to onboard with every manufacturer they trade with. You can see why the 2023 deadline feels like it’s coming up very quickly.

The testing phase is critical because there are challenges such errors in master data files that cause failures, this includes timestamp issues or missing data.

For a manufacturer, it’s not necessarily enough to correct individual files, they also have to look at why the file failed and if a process change needs to happen to prevent that for the future. 

So, a few of tips if you’re new to this type of data sharing :

  1. EPCIS-formatted messages are usually generated through L4 enterprise systems. If you have low volume or low frequency shipments and don’t plan to invest in an L4 system, there are options for generating EPCIS messages. Check with your IT folks to see if they can extract information and formulate EPCIS files. Otherwise there are solution providers that will take data in most any form and convert it for you.
  2. Get help ASAP if you need it. The panelists recommended that manufacturers look into conformance testing companies that will help you learn EPCIS or help you be able to test rapidly.
  3. Exception management is critical. Have processes—resources, tools, and SOPs—for exception management. Product can and will pile up at the dock or be quarantined if distributors don’t have serialization data to receive it against. If your distributor finds a data issue, you need to have alerts in place to quickly react to it.

Time is really of the essence here. There’s not much time left between now and 2023 and there is a lot of onboarding that needs to happen to ensure regulatory requirements are met and that pharma products continue to move through the supply chain and reach patients.

In the full article, there’s a lot more detail. Thanks and see you next time at Take Five video.