Case Study | Serialization and traceability in pharmaceutical packaging

“Our business depends on our flexibility and speed of response. UniTrace makes it faster, easier and more reliable to connect with our customers.”

– Kunal Gupta, CEO Nutra-Med Packaging

Customer

Nutra-Med Packaging LLC provides packaging and repackaging services for pharmaceutical, OTC, medical device, diagnostics and dietary supplements in the U.S. and Canada.

Whippany, New Jersey, USA

300,000-sq-ft facility with 31 packaging lines and 800 associates

Focus areas: Blister packaging, bottling, vials, prefilled syringes, specialized kitting, cartoning and serialization and aggregation operations for a variety of dosage forms and devices.

Challenge

Complex compliance requirements

As a hospital unit dose repackaging service provider, Nutra-Med has highly specialized compliance requirements around transformation, which involves taking finished goods, recording the serial numbers and associating them with new finished goods. In 2017, Nutra-Med began the search for a new compliance software provider when they needed to onboard three new customers quickly. One of their largest customers gave a particularly aggressive deadline: If Nutra-Med was not able to transmit data electronically via its L4 by a certain date, it could jeopardize their ability to do future business together.

Vendor after vendor failed to find a way to address their problem. For repackaging, Nutra-Med must take large quantities of bulk product bottles from existing lots, scan them for transformation, then repackage the content of those bottles into cartoned blister output lots of serialized finished product. Generating compliant EPCIS shipment files requires deliberate methods of storing and combining raw XML data into final files that meet US Drug Supply Chain Security Act (DSCSA) regulatory requirements. The solution needed to be compatible with data from a legacy serialization solution and work with more than 50 customer connections spread out across various endpoints, including custom ones. To make matters even more difficult, resources for equipment, training and support were scarce at the time, as initial DSCSA implementation deadlines had been delayed.

“Having full item transfer visibility and true traceability gives you critical speed and responsiveness to deal with potential problems. If there is an issue with possible counterfeit drugs—which is the whole reason why serialization exists—you don't want to have to wait for someone else to respond. It's your quality, it's your name, it's your profits.”

Solution

Powerful L4 delivered on time

Systech understood Nutra-Med’s challenges and configured a solution that provides seamless and secure data exchange with a wide range of customers. Part of a larger full-stack platform that would scale with the company’s growing business, Systech’s UniTrace® software helps maintain global compliance while enabling end-to-end supply chain traceability. Systech teams developed a way for the solution to onboard numerous connections without major configuration, and Nutra-Med beat the aggressive deadline ahead of its larger competitors. 

Benefits

Faster onboarding, new business wins

Systech’s highly configurable UniTrace solution maintains data compliance throughout Nutra-Med’s complex repackaging process and supply chain, and it enables the company to easily onboard customer connections at any endpoint.

During the company’s initial connection setups, teams systematically learned from what worked and didn’t work so they could develop standard templates to speed onboarding. Now, building customized channels for new implementations can be done in a matter of days or even hours. 

“One question we always get when we’re onboarding a new customer is how long will it take for us to connect with their systems,” Gupta said. “My response is always, ‘That depends on your resources.’ On our side, whether internally or through Systech, we’ve likely already connected with their endpoint in the past. So now the limiting factor is how fast the customer can move.”

Since beating their crucial initial deadline, Nutra-Med has gone from being their customer’s smallest contracting packaging partner to becoming their largest. “How we were able to execute in collaboration with Systech has opened up a tremendous number of additional opportunities and doors with our customer and others throughout the industry.”

How can Systech help you meet regulatory requirements?

Tell us a little about your serialization and traceability requirements, and a Systech solutions expert will be in touch to learn more about your unique supply chain challenges.