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DSCSA Enforcement Readiness: Check

Pharmaceutical contract packager Reed-Lane works with consulting firm, machinery vendors on three key packaging lines to meet fast-approaching serialization enforcement deadline.

Top Three Takeaways:

  • Implementing serialization and aggregation at once benefits Reed-Lane and its customers.

  • An experienced consulting service helped identify preferred solution supplier-partners.

  • As employees become familiar with serialization, they identify with being a part of an issue that is “redefining the industry.”


One can only imagine the number of calendar alerts set to trigger pharmaceutical professionals come Nov. 26, 2018.

Of course, that’s the date the Drug Supply Chain Security Act (DSCSA) serialization enforcement deadline takes effect in which manufacturers must provide unit-level product identifiers on their drug packages. The 2018 date represents a one-year delay granted by FDA in the enforcement of the requirement for manufacturers to affix or imprint product identifiers. Actual DSCSA compliance was Nov. 27, 2017.

Although studies have shown that some pharma manufacturers and contract packaging/contract manufacturing organizations have a way to go to meet the upcoming enforcement deadline, Reed-Lane is in good shape.

Headquartered in Wayne, NJ, Reed-Lane is a pharmaceutical contract packager (CP) that provides packaging to the pharmaceutical market for both prescription and over-the-counter products. FDA-audited, and Drug Enforcement Administration-licensed to package class III-V drugs, Reed-Lane specializes in blister packaging, bottling, wallet carding, pouching and convenience vial filling for solid-dose products as well as secondary packaging and kitting. With new cold storage capacity, Reed-Lane is positioned to label and package temperature-controlled products.

To help its customers meet the serialization enforcement deadline, the CP employed Vantage Solutions, a manufacturing productivity organization that works in strategic guidance, serialization, compliance and automation.

Reed-Lane first encountered Vantage at a serialization seminar where the consulting group’s Portfolio Director Frank Guthrie was speaking. At that time, Vantage was consulting with one of Reed-Lane’s customers.

“We first engaged with Vantage Solutions as a subject-matter expert on the validation of the transmission of data from our carton serialization line to our Level 4 system,” notes Reed-Lane Chief Financial Officer Carmine Sodora. “Shortly thereafter, we initiated a project to implement serialization with aggregation into two existing solid-dose bottle filling lines.”

Richard Wrocklage, Reed-Lane’s Director of Package Development, explains that the project involved the purchase of a new labeler, equipment to print serialized data carriers and aggregate bottles to cases and cases to pallets, and to receive and transmit serial numbers and finished batch files.

“The equipment needed to be integrated into two active lines,” he says. “It was critical that the impact on the operation of these lines for implementation of this project be kept to a minimum.

“Having already purchased, installed and qualified a carton serialization line, we understood the additional complexities that serialization added to the packaging process. We knew we would benefit from the diverse knowledge and experience Vantage displayed on our previous engagement.

“As a contract packager we strive to give our customers a high level of confidence by partnering with suppliers that are established as leaders in the industry. We found that Vantage had experience with the preferred vendors for this project: Optel Group, NJM, Domino and TraceLink.”

Vantage provided Reed-Lane with assistance on multiple aspects of its serialization project, including the following:

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LAST CHANCE TO SAVE! New Tech for Life Sciences at PACK EXPO Southeast