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.
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.”
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.
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 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.
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 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, (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.
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.