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Type: Blog
Section: Logistics > Traceability/Serialization
Pharmaceuticals
UDI and the approaching end of the NDC
FDA’s definition of UDI and its mandate should bring the same benefits to medical devices over the coming years that the National Drug Code has to standardization in its market.
November 8, 2013
Dirk Rodgers
Traceability/Serialization
The healthcare community and the government shutdown
What’s the impact from the just-ended shutdown for makers of pharmaceuticals, biologics, and medical devices? Give us your opinion.
October 18, 2013
What does the recently ended government shutdown mean for the healthcare community?
Pharmaceuticals
Working with CMOs under California e-pedigree
For different products, manufacturers may fill the role of an exclusive distributor, a contract manufacturing organization, or a repackager. Each of these would be treated differently under the California law with respect to pedigree origination and updating.
August 28, 2013
Figure 1. Manufacturer A is probably acting as a contract manufacturer/packager on behalf of the NDA holder, manufacturer B.
Pharmaceuticals
Will generic pharmaceutical manufacturers serialize their drugs in time?
Consider what impact it might have on your business if your company is not ready.
July 11, 2013
Dirk Rodgers
Pharmaceuticals
Boosting security in the pharmaceutical supply chain with serialization
Serialization benefits extend beyond compliance to patient safety, to brand reputation, and to a better understanding of your supply chain process.
June 18, 2013
This photo shows lot number, manufacturing date, expiry date, product information—alphanumeric and 2D DataMatrix code printed by a Wolke thermal ink-jet printer from Videojet.
Pharmaceuticals
Serialization: A universal challenge yields staggering survey results.
Complexity of a flexible data management solution, regulatory uncertainty, and lack of upper management understanding slow progress.
May 30, 2013
Jim Chrzan, Healthcare Packaging Publisher
Pharmaceuticals
Could federal bills supersede California's e-pedigree?
Pending legislation would only address pharmaceutical lot-level track and trace, according to this report from the Global Track & Trace Roundtable in NJ.
May 9, 2013
Jim Chrzan, Healthcare Packaging Publisher
Materials
Serialization: EU's track and trace versus U.S.'s e-pedigree
Healthcare Packaging Publisher Jim Chrzan talks with Barry McDonogh and Dave Harty from Systech International, clarifying the enormous challenge ahead.
March 20, 2013
Barry McDonogh (left) and Dave Harty
Materials
Will California e-pedigree dates slip again?
Healthcare Packaging welcomes columnist Dirk Rodgers in discussing pharmaceutical track-and-trace technology, standards, and regulatory compliance issues.
January 9, 2013
Dirk Rodgers
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