Track and Trace

Sharp Packaging Solutions Launches White Paper on Serialization

Sharp Packaging Solutions released a white paper at the Pharma Packaging Labelling Summit in Zurich in June on the challenges around serialization, titled “Product Serialization to Advance Pharmaceutical Authentication and Patient Safety.” 

SSI Schaefer’s Order Verifier Streamlines Track and Trace Requirements

SSI Schaefer announced it has developed an automated solution, the SSI Order Verifier, to verify and document orders prior to shipping. The move is in response to the Drug Supply Chain Security Act and the new FDA regulations mandating distribution of pharmaceutical products require high-speed camera-based scanning, integrated with automated labeling to track and trace shipments. 

Open-SCS Working Group Addresses Compliance with Healthcare Anti-Counterfeiting Standards

The Steering Committee of the Open Serialization Communication Standard Working Group (Open-SCS) addressed compliance to healthcare counterfeiting regulations recently by announcing the accelerated development of an industrial interoperability standard and associated requirements templates for release by the end of 2015. The scope of work products focuses on healthcare packaging serialization interoperability across the plant’s equipment, systems, and between the supply chain systems.

FDA Releases Compliance Policy for Dispenser Tracing Requirements

The Federal Drug Administration released the document DSCSA Implementation: Product Tracing Requirements for Dispensers — Compliance Policy Guidance for Industry. The guidance addresses the readiness of dispensers in the pharmaceutical distribution supply chain to comply with the provisions in section 582 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C.

TraceLink Boasts Cutting First-Year DSCSA Costs for U.S. Wholesale Distributors Through Cloud Data Service

TraceLink Inc., a global largest track and trace network for connecting the life sciences supply chain and eliminating counterfeit prescription drugs from the global marketplace, announced that United States wholesale distributors currently managing a mix of paper and electronic compliance documents under the U.S. Drug Supply Chain Security Act (DSCSA) can reduce their compliance infrastructure and labor costs by more than 70 percent in the first year as a TraceLink customer.

Optel Vision Launches Open SiteMaster Software to Boost Data Exchange for Serialization

Optel Vision announced its launch of the first non-vendor locking site server, the Open SiteMaster, geared to improve data exchange for serialization without annual license fees.

Unique Coding, Over the Years

Over the years, PMP News has been tracking the need for product coding at item levels. In “Cutting Edge Coders” from the October 1995 issue, for instance, then features editor Jennifer Reid Holman wrote that “the latest computer-operated printers—including new models of thermal-transfer coders, ink jets, and laser coders—offer more variability.
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Preparing For A New Traceability Law

A national law provides a phased-in approach leading to the electronic tracking of uniquely-coded packages.
By David Vaczek, Senior Editor
The pharmaceutical supply chain will be reevaluating plans and investments for tracking product with the passage of H.R.
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Senate, House Reach Agreement On National Traceability Law

The prospect of federal track and trace legislation has leapt forward with the passage on Saturday by the House of Representatives of a bill negotiated between House and Senate committee leaders last week.

Congress Moves Toward National Standard For Drug Product Tracing

As Congress attempts to find common ground on a national tracing system for pharmaceuticals, the supply chain is preparing for current serialization requirements in California and globally.
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