Supply Chain

Sartorius Stedim Biotech Launches Supply-Chain Initiatives

Sartorius Stedim Biotech (SSB) is launching a new initiative for “end-to-end” security across the entire supply chain spectrum. The supply-chain security initiative will cover three elements: membership in the RX-360 Consortium, implementation of global guidelines for wooden pallets, and tamper-evident packaging.

Industry Seeks Track and Trace Law

By David Vaczek, Senior Editor

With buy in from all pharma supply chain sectors, the RxTEC Act provides a model for automated lot-level tracking.

With the RxTEC Act, pharmaceutical supply chain members are proposing a phased-in approach to track-and-trace with a federal law imposing uniform requirements on all states.

Delta Cargo to Accept GPS-Enabled Sensors throughout Global Network

The airline’s network will be able to track cargo and transmit data around the world, even in the remote or rural regions it serves.

Pharmaceutical and biological product shippers will be able to track the condition and status of their cargo across the entire Delta Air Lines and Delta Connection fleet, which operates more than 5000 daily flights to more than 340 destinations, 61 countries, and six continents. Delta Air Lines has received FAA approval to use SENTRY 400 FlightSafe devices from OnAsset Intelligence (www.onasset.com) on all of its main-line and connecting flights, giving shippers product visibility throughout aviation distribution.

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Filling in the Engineering Gap

A new consultancy aims to provide technical support to those preparing products for the cold chain.

One of the most common mistakes in preparing products for the cold chain is using the wrong shipping profile, reports Gary M. Hutchinson, formerly director of global transportation at Amgen. “As a result, companies could be over designing or under designing their packaging systems.” Such a mistake means that companies could be spending far too much on their systems—or protecting their products far too little.

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Healthcare Supply Chain Executives Ask for Release of FDA's Proposed UDI Rule

A group of health care organizations have written a letter to Jeff Zients, Acting Director of the Office of Management and Budget (OMB), asking for the release of FDA's proposed rule on Unique Device Identifiers (UDIs). According to FDA, Section 226 of the Food and Drug Administration Amendments Act of 2007 (FDAAA) directs FDA to issue regulations establishing a UDI system for medical devices. This system is intended to improve the identification of devices throughout distribution and use.

The associations that submitted the letter are:

Managing the Supply Chain

Packaging and labeling technologies can be used to fight supply-chain threats, but they must be part of an overall strategy.

The pharmaceutical industry is no longer defined—or confined—by borders. Manufacturers are sourcing ingredients, materials, finished products, and contract packaging and manufacturing from around the world, and most are seeking to serve patients in multiple markets. The resulting supply chain is a complex one.

“Things are changing,” says Brian Johnson, senior director, supply-chain security, Pfizer Inc. “Markets are expanding, and where we are sourcing materials and manufacturing is changing.”

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Novartis Shutdown Could Cause Supply Problems for Endo

In a press release issued by Endo Pharmaceuticals, the company expressed concerns that the halting of production at Novartis Consumer Health’s manufacturing facility in Lincoln, NE—coming on the heels of production and packaging problems—will lead to short-term supply constraints for its pharmaceutical offerings.

USP Seeks Broad Feedback On Supply Chain Integrity Standard

As the pharmaceutical industry continues to globalize, the challenges of securing complex supply chains and protecting patients from counterfeit medicines, as well as the consequences of lapses in security or proper handling, have mounted. In an effort to encourage comprehensive public standards across the pharmaceutical industry, the U.S. Pharmacopeial Convention (USP) is proposing a set of recommended best practices that will help ensure that medicines can be traced back to their original manufacturer, are not adulterated or counterfeited, and are transported to their intended destination with their quality intact.

Web Sightings

The European Medicines Agency
www.ema.europa.eu

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TÜV Rheinland Industrial Solutions Forms Containment Emergency Response Team

TÜV Rheinland Industrial Solutions has introduced a new emergency rapid response service called Containment Emergency Response Team (C.E.R.T.). Developed to minimize OEM production disruptions when out-of-specification products have entered the supply chain,  C.E.R.T. is made up of certified inspectors who can respond nationally and internationally to suspected quality issues throughout the supply chain.

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