Track and Trace

Brazil Works Out Elements of Its Plans For Serialization

The regulating agency has proposed pre-encoded labels supplied by the government.

Brazil’s schedule for establishing serialized packaging has been side-tracked, as industry debates what the program should look like.

The country’s regulatory authority, ANVISA, has outlined requirements for a traceability system, following national legislation that sets out an aggressive three-year time table for a full track-and-trace solution.

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Track and Trace: The Next Step from Vision

If you are ready for 100% label verification, track and trace may not be too much of a leap.

If you are inspecting packages and storing the results of those inspections in an event repository to track package compliance, you may be closer to a track-and-trace model than you first thought. “It is the same basis that allows you to build up for track and trace,” explains Niall Carty, vice president of marketing & business development, Crest Solutions. “It is all about feeding data up to an ERP environment.”

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IPEC Urges Track and Trace Mandates, But Will They Materialize?

Drug firms are working to secure their own supply chains, but will individual efforts close all the gaps in the supply chain?

In June, Victoria Espinel, Intellectual Property Enforcement Coordinator (IPEC), Office of Management and Budget, testified before Congress about drug counterfeiting. Her office is establishing an interagency committee to combat counterfeiting, and her team will take on unlicensed Internet pharmacies and counterfeit drugs both in the United States and around the globe. “And to further guard against the proliferation of counterfeit drugs, we will increase our enforcement efforts and cooperation with relevant agencies, including CBP, DEA, and FDA,” she testified.

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System Support for Track and Trace

OM HealthCare Logistics employs Red Prairie’s warehouse management system for medical device and pharmaceutical distribution and management.




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GS1 US Releases 2010 Annual Overview, Revamped Web site

GS1 US has released its 2010 Annual Overview, which outlines the role of GS1 US, case studies, and descriptions of important industry and GS1 US initiatives, such as food safety, data accuracy, and sustainability.

EMD Serono Builds Out Track And Trace Solution

The drug manufacturer has developed a global solution for track and trace to promote patient safety and to meet legislative mandates.

EMD Serono Inc.’s (Rockland, MA) development of secure supply-chain systems began in 2002 with pharmacist authentication of serialized packages of its human growth hormone drug Serostim.

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FDA to Speak at Upcoming U Connect Conference

Dennis Baker, Regional Food and Drug Director, FDA’s Southwest Region, will speak about the agency’s efforts to improve the supply chain during a keynote address on June 9 during the upcoming U Connect Conference. Hosted by GS1 US and its conference partner VICS, the event will cover standards-based business processes and best practices for managing the supply chain efficiently.

Systech and Videojet Team To Support Track and Trace In Brazil

Systech International and Videojet Brazil announced a partnership to help pharmaceutical manufacturers to effectively meet the country’s quickly emerging regulatory requirements for encoding and marking solutions. In the partnership, Videojet will sell, install, and support Systech’s serialization solution in Brazil.

BD Reaffirms Commitment to GS1 Data Standards

BD, (Franklin Lakes, NJ) reiterated today its commitment to globally recognized GS1 data standards to help enhance patient safety efforts, improve supply chain efficiency, and reduce healthcare costs.

BD began using GS1 data standards in 1972 to help enhance its supply chain processes. Since that time, the company has been a vocal advocate for industry-wide adoption and an active participant of the GS1 Healthcare US™ Leadership Team and workgroups.

New Track-and-Trace Solution Debuts from Crest Solutions and Eisai Machinery U.S.A. Inc.

Crest Solutions (Cork, Ireland) and Eisai Machinery U.S.A. Inc. (Allendale, NJ) have joined forces to launch a new track-and-trace packaging system that supports compliance with multiple local and international regulatory requirements in the pharmaceutical industry. The PharmaMarker system is designed to integrate easily into pharmaceutical production and packaging lines to facilitate pharmaceutical coding and traceability. The system was highlighted at Interphex April 20-22.

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