Reed-Lane, a contract packaging provider that serves leading pharmaceutical manufacturers, recently completed three serialization projects to comply with the FDA's Drug Supply Chain Security Act (DSCSA). The law mandates that each saleable unit of a prescription drug product intended for the U.S. market (e.g., carton, tray, bottle or case) be imprinted with a unique barcode by Nov. 27, 2018, to defeat counterfeiting.
Reed-Lane's projects included a "Level 4" integration of its carton serialization line with its business systems as well as bringing serialization with aggregation to two solid-dose bottling lines.
"It was essential to do these projects right the first time and to minimize the impact on our operations," said Carmine Sodora, chief financial officer of Reed-Lane. "Vantage had the know-how and experience to help us feel confident in handing them the keys. They kept us on track, well-coordinated and productive throughout."
The project involved new equipment for: printing serialized bar codes; labeling; aggregating bottles to cases and cases to pallets; receiving and transmitting serial numbers and moving batch data files.
Vantage supported all stages of the implementation, which included:
- Development of User Requirement Specification (URS).
- Factory Acceptance Testing (FAT)/ Site Acceptance Testing (SAT) plan development and execution of SAT.
- Installation and start-up support.
- All validation protocol development and execution support.
- Validation Master Plan development and modification/creation of standard operating procedures for the serialized lines.
"A lot of moving parts were involved, figuratively and literally, and Vantage kept the project and the voluminous documentation organized, on schedule and within budget," said Joseph Byrdak, Reed-Lane packaging process engineer. "The project required extensive coordination of multiple vendors, and Vantage had solid, pre-existing relationships with all of them."
The vendors included Optel, NJM, Domino and TraceLink.
"Serialization is complex and many packagers have legitimate concerns regarding the prospect of outages and slowdowns as they undertake conversions," said John Jordon, President, Vantage Solutions. "As our partnership with Reed-Lane illustrates, thoughtful planning, careful execution and close collaboration at every step can minimize the disruption – and help you come out more productive."
About Vantage Solutions
Vantage is the manufacturing productivity company. For manufacturers facing safety, quality, or efficiency challenges, we provide strategic guidance and cost-effective execution of initiatives to improve serialization, packaging, inspection and more. Our team is seasoned, lean, on time and within your budget. www.vantage-cg.com.
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