Unitrans Life Sciences Logistics Newsletter | Edition 3 | April 7, 2015
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In Edition 3:
Coldchain Comments:Controlled Room Temperature IC&S
Industry, Carrier and Service updates
Security Updates: Counterfeiting Intell, Webinar
Compliance Corner: Product Tracing Requirements policy

Links of the Week




Coldchain Comments

Envirotainer™ has received full Federal Aviation Authority (FAA) approval for the RAP e2™ container. As all Envirotainer™ unit load devices now have FAA approval, any/all containers may be flown on U.S. flag carriers and others subject to FAA regulations. Carriage is also subject to individual carrier authorization internally.

Controlled Room Temperature (CRT) is one of the fastest growing and most challenging temperature ranges for logisticians to manage. In their white paper, The Hitchhiker's Guide to Controlled Room Temperature, IQPC's Cold Chain IQ, in association with Coolchain Logistics Europe, defines 8 steps to maintaining CRT compliance.

Recognizing the importance of pharmaceutical coldchain compliance, Etihad Cargo has developed TempCheck™ for the protection of temperature controlled pharmaceutical cargo. The service utilizes a specially designed passive, pre-cooled thermal ULD covering which surrounds actively cooled Unit Load Devices during load staging planeside on the tarmac.

Industry, Carrier and Service updates:

AIRFREIGHT: The post-merger integration of American Airlines and US Airways is almost complete. Effective April 8th, the FAA will grant the carrier its Single Operating Certificate (SOC) allowing both carriers to operate under the American Air Carrier Certificate – AALA025A. The cargo divisions of the two carriers have been integrated under a single cargo air waybill, resulting in one of the largest air cargo operations in the world. Following additional integration work on IT and other systems, we anticipate improvements and efficiencies to result for air cargo customers.

In related developments, American is re-examining the role of Charlotte, NC (CLT) as their 2nd largest network hub (Dallas is the largest). American's hub at CLT works because of low costs. However, a law capping jet fuel taxes at $2.5 million a year will expire later this year causing fuel bills to rise significantly.

SEAFREIGHT:From World Maritime News we learned two of the world's biggest container liners – Maersk Line and the Mediterranean Shipping Company (MSC) have, through their 2M vessel sharing alliance, introduced a fourth service between North Europe and the United States starting this April.

TRUCKING:Life on the road can be tough. Long hours behind the wheel, poor diet choices, lack of exercise and obesity haunt many professional drivers. Prime Inc. is helping to promote an industry fitness initiative with its 3rd annual "Fittest Trucker in America" Competition. Helping drivers to lose weight and adopt more healthy lifestyles – what a great idea to promote.

MEDTECH/DEVICES: The Best Kept Secret Behind Israel's Top Medical Devices. Presents a look at Taga engineering and design.

DIAGNOSTICS: As the industry moves to develop more personalized medicines, Quintiles and Quest Diagnostics are combining forces in a new joint venture. The goal is to do a better job identifying the right patient for the right trial at the right time.

BIOPHARMA: Seattle based Omeros launches Ormidrea as years of trials, millions in R&D and the arduous FDA approvals process deliver for a product used during cataract surgery.

BIO 2015 Exhibition is coming to Philadelphia June 15-18, 2015. For a list of exhibitors, program schedules and registration information click here.

Security News

From our colleagues at PCSC and BSI: BSI will be hosting a webinar on April 30th, at 2pm ET, to discuss counterfeiting intelligence within pharmaceutical supply chains - and how to effectively identify areas/regions where this type of activity has been seen, as well as how to manage a supply chain to mitigate that threat. The webinar will provide information about how implementing the proper risk management solutions and services can successfully increase your supply chain visibility, supplier compliance and reduce the risk of counterfeiting opportunities

Compliance Corner

The Food and Drug Administration (FDA) has announced the availability of a guidance for industry entitled "DSCSA Implementation: Product Tracing Requirements-Compliance Policy." To view and/or comment, the guidance explains FDA's intentions for enforcement of the product tracing requirements of the FD&C act as added by the Drug Supply Chain Security Act. FDA does not intend to take action against trading partners who do not, prior to May 1, 2015, provide or capture the product tracing information required by section 582(b)(1), (c)(1), and (e)(1) of the FD&C Act.

Questions?  Comments? Ideas? We’d love to hear from you @ dave.janzow@unitrans-us.com




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