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Section: Logistics > Traceability/Serialization
Pharmaceuticals
Inference: The importance of aggregation accuracy
Pedigree laws that mandate unit-level serialization, like the California pedigree law, require members of the supply chain to certify shipment and receipt using unit-level serial numbers.
December 27, 2013
Inspection
Packaging line modifications for serialization
Line serialization, while a significant investment in time and money, is less strategically taxing than sharing the data internally from each line and plant up through the enterprise, and with your trading partners.
December 27, 2013
Pharmaceuticals
11 routinely underestimated aspects of serialization
While there are untold gotchas in any project, here are the areas that are most overlooked or shortchanged, based on feedback from those who’ve been there.
December 26, 2013
Pharmaceuticals
11 steps to getting started with serialization
Ready to begin? Here’s a roadmap of how to get started.
December 26, 2013
Robotics/Automation
Secrets to serialization project management
Serialization involves multiple, complex technology components—package execution controllers, Supervisory Control and Data Acquisition (SCADA), PLCs, machine vision, sensors, scanners, encoding, inspection and verification systems—all feeding information to complex IT layers—device-level, line-level, plant-level, enterprise, networked to outside trading partners.
December 26, 2013
Traceability/Serialization
Staffing for success: Building a proper serialization team
Serialization requires input both at the planning stage and during execution from multiple departments as well as external trading partners.
December 22, 2013
Pharmaceuticals
It all started with California
While a few of the major pharmaceutical manufacturers jumped in early in order to create a system flexible enough to do business in multiple foreign countries, California’s announcement in 2004 really got the attention of industry.
December 21, 2013
Supply Chain
RFID and barcode data capture interoperability
The track-and-trace solution you select should be capable of easily handling item identification and serialization data capture from both RFID and barcode data carriers.
December 20, 2013
Adherence/Delivery
Your Top 10 Healthcare Packaging stories from 2013
Serialization stories dominated the list among Healthcare Packaging online readers, but the top-read story of the year revealed some dirty deeds.
December 19, 2013
Materials
Global compliance: Flexibility is the key
To accomplish the successful deployment of a global serialization program, flexibility is the key.
December 19, 2013
Materials
GS1 standards involved in serialization
With so many players in the supply chain poised to exchange data, it’s important that the industry coalesce around a common set of standards to ensure interoperability and scalability of integrations.
December 18, 2013
Pharmaceuticals
Serial number management, certifications, and pedigree reporting
Serial number management is a set of functions that will allow you to securely and accurately control and keep track of the serial numbers you apply to your pharmaceutical or biologic products.
December 16, 2013
Pharmaceuticals
The business case for serialization
While the e-pedigree regulations in Turkey and California may have been your catalyst for serialization, completed projects reveal a wealth of business benefits—some anticipated, some surprises!
December 15, 2013
Pharmaceuticals
DQSA would replace the patchwork
In the fall of 2013, the U.S. House of Representatives passed the Drug Quality and Security Act (DQSA), a bill that would regulate compounding pharmacies and would impose a phased-in nationwide serialization and e-pedigree regulation.
December 14, 2013
Pharmaceuticals
Not just ‘why,’ but ‘how’
Miracles still happen. In the fall of 2013, the U.S. House of Representatives and Senate passed the Drug Quality and Security Act (DQSA), a bill that will regulate compounding pharmacies and would impose a phased-in nationwide serialization and e-pedigree regulation.
December 11, 2013
Pharmaceuticals
Pharmapack Europe 2014 focuses on innovation
Feb. 12-13 event, now at the Porte de Versailles, will concentrate on packaging and delivery systems for medications and healthcare products.
December 10, 2013
Pharmaceuticals
H.R. 3204 bill signed into law
Establishes national track-and-trace/serialization system and brings more federal oversight to large-volume compounding pharmacies that custom-mix medications in bulk.
December 2, 2013
Pharmaceuticals
GS1, UPS hail Senate passage of H.R. 3204
Industry leaders praise bill with enhanced track-and-trace initiatives for the pharmaceutical supply chain.
November 19, 2013
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