It has been a long time in coming, but the International Air Transport Association (IATA), the  240 member inter-airline organization promoting safe, reliable, secure and economical  air services for the benefit of the world's consumers, has undertaken a significant step for improving the handling of temperature-sensitive pharmaceutical products. The organization, representing more than 140 nations is adding a separate chapter to its 7Th Edition of the Perishable Cargo Manual specifically addressing air transport logistics for temperature-sensitive health care products.

The current edition to the manual is primarily dedicated to perishables of the flora and fauna variety, with only vague guidelines for handling medicinal products.

Late last summer I was contacted by Eric Raemdonck, Secretary of the Live Animals and Perishables Board (LAPB), and Manager of Special Cargo Standards at IATA, and asked to form and chair a cross-industry committee consisting of representatives of pharma, freight-forwarders, airlines and service providers whose purpose would be to:

- provide information on the factors that affect temperature-sensitive health care products 

-  indicate critical control points in the air transport logistics that can impact products

-  provide best practices conforming to regulatory agencies requirements.

It has been quite an undertaking and over the last several months the airline industry, through the LAPB has demonstrated extraordinary cooperation with the Pharmaceutical industry and other service providers for establishing concise, practical guidelines for shippers handling health care products to ensure an industry-wide standard of excellence. 

Since the pharmaceutical industry is one of the most heavily regulated industries in the world, every step of the life-cycle process, including manufacturing, storage, distribution, application and disposal must be well defined and follow very strict government agency guidelines.

 

The guidelines for handling  in the 7Th Edition of the Perishable Cargo Manual to be published in June 2007, will, for the first time, be binding to its members. This is a significant stroke of good fortune for the pharmaceutical industry as improvements to the  process should be immediate and positive since this portion of the distribution chain has long been identified by the pharmaceutical industry as a major gap in lack of control within the distribution process, rife for mishandling - with significant potential for exposure to temperature extremes and improper storage.

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