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633 Results

Section: Logistics > Traceability/Serialization

Pharmaceuticals

Determining goals and metrics for pilot testing

There are two schools of thought when it comes to pilot testing.

January 10, 2014

Traceability/Serialization

Contract manufacturing and contract packaging strategic considerations

It’s become a fact of life that the North American pharmaceutical industry, while still firmly rooted in manufacturing of its own products, also makes heavy use of outsourcing to contract manufacturing/contract packaging organizations.

January 8, 2014

Robotics/Automation

Line- and plant-level software implications

While GS1’s Electronic Product Code Information Services (EPCIS) protocol standardizes the way serialization data is transmitted between trading partners, there is no such standard for communicating between a company’s internal serialization solution and its Manufacturing Execution System (MES), Enterprise Resource Planning (ERP) systems such as SAP, and ERP modules that handle serial number management (such as Aii in the case of SAP). And therein lies the rub.

January 8, 2014

Pharmaceuticals

Preventing counterfeit e-pedigree data

Although many people may think of serialization and e-pedigree as the industry’s final checkmate in the counterfeit arms race, nothing could be further from the truth.

January 7, 2014

Robotics/Automation

How to avoid the leading zero issue

There are a number of layers of software systems involved in serialization: line- and plant-level serialization systems, ERP-level serial number management systems, and network-facing EPCIS systems.

January 7, 2014

Pharmaceuticals

Impact on wholesaler/distributors, pharmacies, clinics, and hospitals

Wholesaler/distributors face an incredible challenge. They will receive data from hundreds of suppliers—and must disseminate it to thousands or tens of thousands of customers—and have to figure out how to manage it all.

January 6, 2014

E-pedigree models and the U.S. drug supply chain

The debate over pedigree regulatory models in the U.S. pharmaceutical supply chain often centers on how much data for each package of drugs needs to be moved between trading partners as those drugs physically move through the supply chain.

January 6, 2014

Pharmaceuticals

Impact on production/operations workflows

Pharmaceutical companies are finding that the cost to upgrade a typical packaging line for serialization runs at around $1 million, give or take. With that level of investment, it’s only natural to focus on the equipment and engineering changes involved in reconfiguring the line itself.

January 5, 2014

Pharmaceuticals

Questions to ask your CMO/CPO about serialization

While the focus of many pharmaceutical manufacturers is on their own internal infrastructure, it’s prudent for manufacturers to begin surveying their contract manufacturing and contract packaging organizations for serialization readiness.

January 5, 2014

Business process considerations for mixing serialized with non-serialized shipments

You might need to implement special business processes for handling serialized versus non-serialized shipment processing with your supply chain partners during piloting.

January 5, 2014

Traceability/Serialization

Validation considerations for serialization

As a rule of thumb, validation adds 25% to the cost of any changes required by serialization.

January 4, 2014

Traceability/Serialization

Impact on production line speeds and OEE

Of utmost concern to production/operations teams is the impact serialization will have on production line speeds.

January 4, 2014

Pharmaceuticals

A perspective on DQSA, preemption, and pedigree

Now that DQSA is law, any previous investments to meet California pedigree law can be repurposed to meet the new federal law.

January 1, 2014

Pharmaceuticals

Label and panel redesign considerations

Often left out of the equation in early pilot tests, many package design professionals have discovered the hard way that serialization has a deep impact on labels and panel design.

December 30, 2013

Labeling/Printing

How to avoid a big barcode gotcha

With mass-produced packaging, barcodes are preprinted as part of the package artwork. As such, no one has had to really worry about whether those codes will scan throughout the supply chain.

December 29, 2013

Vision system considerations

One of the key considerations for vision systems pertains to the industry’s predominant use of round bottles.

December 29, 2013

Labeling/Printing

Nine coding and markingconsiderations for serialization

While the long arm of serialization reaches deep across multiple silos in the organization, one could say it starts with the physical code applied to the package. There are several things to consider.

December 29, 2013

Packaging/Filling

Strategies for accurate aggregation

The actual electronic association of the serial numbers of individual unit packages to a case is done after an inspection system on the packaging line visually inspects individual packages (or they are manually scanned) upon going into the shipping case.

December 28, 2013

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