pharmaceuticals
INTERNATIONAL AIRLINES are divided over the question of whether US Transportation Security Administration (TSA) regulations demanding piece- level screening of all passenger aircraft bellyhold cargo, which came into effect 1 August, are having an adverse impact on pharmaceutical shipments. Oliver Evans, chief cargo officer for
Swiss International Air Lines, said such shipments frequently fly as bellyhold cargo. If they were to be opened for inspection, products might suffer damage due to a change in temperature or atmosphere. “We think it is outrageous that
pharma shippers are being deprived of the choice they might want to make, together with their forwarders, to use airlines like ours that have depths of expertise and experience
in handling pharma shipments and are being forced to look at certain freighter carriers which might not have that experience or expertise,” Evans argued. “Together with pharma shippers and
the TSA, we are finding some solutions and work-arounds so we have only lost a small amount of business, but the trend is disturbing.” Evans assured: “We will be lobbying
with the US authorities and pushing for the restoration of a level playing field.” However, Joe Reedy, vice president sales and marketing for American Airlines Cargo, played down the issue. “We have not seen any business that we were previously carrying adversely impacted and I am not aware that it has impacted our ability to pursue any new business,” he remarked.
“Ultimately, the best solution
in relation to pharma traffic is for shipments to be screened by the shipper and many of the pharma companies are doing that. But for the ones that are not, there are alternative ways for us to provide the screening that is necessary to meet the TSA requirements.”
a risk of confusion when you have so many different guidelines,” he observed. However, he also admitted it was difficult to see which organisation could co-ordinate such harmonisation, as each body has different interests. IATA’s Chapter 17 regulations, which include guidance
on the merits of a quality management system found in the International Conference on Harmonization guideline for pharmaceutical quality systems (ICHQ10), were initially introduced in July 2009, with a following one-year period allowed for carriers to fully implement them. “Chapter 17 is attempting to make many things
over-the-counter medicines as well as other healthcare products manufactured or sold in the US;
• The Healthcare Distribution Management Association, the trade association representing healthcare distributors in the US;
• The International Safe Transit Association, an organisation focused on transport packaging which has developed a standard for insulated container performance (ISTA Standard 20); and
• IATA (the International Air Transport Association), which last year introduced new rules (Chapter 17) governing the transport of temperature-sensitive healthcare products. Exelsius Cold Chain Management Consultancy’s Wright
agrees that such a proliferation of bodies makes it difficult to achieve consistent pharma supply chain rules worldwide. “Unless there is some harmonisation, there could be
14 AIR LOGISTICSCHINA
mandatory, right from using a different label to improving ground infrastructure, automated or manual temperature mapping of shipments between facilities, and appropriate SOPs (standard operating procedures) for managing shipments through the transportation cycle,” explained Ramesh Mamidala, manager cargo hub and product development for Emirates SkyCargo.
TRAINING PROGRAMME In a recent development, the introduction of Chapter 17 took a further step forward with the holding of the first related IATA two-day training course that took place in the US. Others are planned soon in Asia and Europe. Wright, whose company Exelsius Cold Chain Management Consultancy won the contract from IATA to develop and deliver Chapter 17 training, said the advent of those courses “takes Chapter 17 on from being a set of rules and guidance into practical implementation”. Many airlines, forwarders and pharma shippers have also this year had to deal with the impact of recently-
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