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OPTEL chosen for US FDA’s DSCSA pilot project for supply chain scrutiny

may 24, 2019 By expressbpd
Tag: FDA , DSCSA , Optel

Serialization and traceability companies selected for the project, like OPTEL, will test new technologies to develop an electronic, interoperable system to help improve the FDA’s ability to trace prescription drugs at every point in the supply chain

OPTEL has been chosen to participate in the US Food and Drug Administration’s Drug Supply Chain Security Act (DSCSA) Pilot Project Program to help identify and trace prescription drugs as they are distributed within the United States, according to the press release issued by the company.

Serialization and traceability companies selected for the project will test new technologies to develop an electronic, interoperable system to help improve the FDA’s ability to trace prescription drugs at every point in the supply chain, with an emphasis on the enhanced requirements for package-level tracing and verification that will go into effect in 2023, it added.

“We are eager to demonstrate how our traceability systems and serialization expertise can help pharmaceutical organizations comply with the FDA’s DSCSA mandates, especially the aggregation requirements that take effect in 2023,” said Louis Turcotte, OPTEL’s Vice-President, Pharmaceutical.

“With three decades of experience and our exclusive ability to provide end-to-end traceability from raw material extraction all the way to the consumer, OPTEL is well positioned to offer the leading-edge solutions required to bring complete visibility to the entire supply chain,” he added.

For the pilot project, OPTEL chosen to focus on interoperability and data/database/system issues and will demonstrate how its solutions can help companies overcome a myriad of supply chain track-and-trace business challenges, such as maintaining the integrity of serialized barcode information, data quality throughout the product life cycle, data access and control, and the ability of the system to record product status at all packaging levels.

According to the press release, to successfully complete the pilot and record its findings, OPTEL will partner with select North American manufacturers, wholesale distributors, and dispensers in the United States. OPTEL expects to wrap up its part of the project by January 2020 and complete the reporting component by the end of February 2020.

“The technologies used to drive OPTEL’s Intelligent Supply Chain solutions will allow many industries to benefit from actionable, real-time data to ensure the quality, integrity and authenticity of consumer products, help stop counterfeiting and reduce waste. We are pleased that through this pilot program, the FDA may leverage our learnings and latest technologies to enhance the security of the drug supply chain in the United States so that all stakeholders can benefit,” Turcotte commented.

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