Domestic Canadian Pharmaceutical Temperature Controlled Distribution



Cold Chain IQ
12/01/2011

Demand for temperature controlled distribution in Canada is only set to grow in the coming years, as the life sciences industry continues along the road to growth and the number of temperature sensitive products continues to rise.

GlaxoSmithKline recently launched a $50 million fund for investment in early stage research and the commercialisation of breakthroughs in the life sciences industry.

Moncef Slaoui, global chairman of Research and Development at GlaxoSmithKline, touted the fund as demonstrating the company's confidence that Canada will "continue to be an important source of development for medicines of value for patients."

Globally, biopharmaceuticals are continuing to push the cold chain market into higher levels of growth, with the market for cold chain logistics expected to climb to $6.9 billion by 2012, according to theBiopharma Cold Chain Sourcebook.

This growth could potentially prove costly for pharmaceutical companies, unless distribution is managed correctly.

Mark Lipowicz, a market analyst and co-author of the report, noted: "Increases in volumes of cold-chain pharmaceutical shipments do not track directly with increased sales because the newest high-value biotech drugs are also increasing in price by more than the industry average.

"Nevertheless, as their sales and volume both grow, and as regulatory requirements continue to tighten, the cost of delivering them will grow."

In Canada, these new regulations come in the form of GUI-0069, released by Health Canada in January 2011, which came into force in April. The guidelines supersede those from 2005 and the beefed up regulations reflect the extremes in temperature likely to be experienced by domestic distributers in Canada.

Receiving bays for the products must "protect deliveries from inclement weather during unloading", written shipping procedures for products must take into account "any seasonal variations experienced" and the selection of containers must be "qualified" for "anticipated extremes of ambient temperature".

0069 is also very clear as to what it classes as a "qualified" container, characterising it as "a package that can repeatedly demonstrate through documented testing, a high degree of assurance that the determined acceptance criteria are met and will maintain the quality of the drug product under such conditions."
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As manufacturing and clinical trials increasingly move overseas, even domestic companies are having to deal with import regulations. Canada, alongside Saudi Arabia, Singapore, Malaysia and Argentina, is one of the countries which has made documentation of individual shipments of cold chain pharmaceuticalsan entry requirement.

In addition to the tightening of the regulation over the cold chain, ambient distribution is also moving up to the priority list.

Speaking last year to Canadian Distribution and Logistics, Daniel Gagnon, director of the Healthcare Logistics Strategy Group at UPS, noted: "A lot of the concern has been on the two to eight degrees Celsius product, while there is more focus now on 10 C to 25 C.

"In many cases, these products would move through the transportation system as regular dry goods, but now you see more shippers taking additional precautions."

As Gagnon noted, shippers are rising to the challenge of the greater demands of the pharmaceutical sector, and its regulatory agencies.

When agencies tighten their guidelines, the new requirements get passed on accordingly.

"Manufacturers, in turn, write contract terms with their logistics providers to ensure tighter control of shipping conditions, and they... seek better service from trucking and air-freight companies," the cold chain sourcebook highlighted.

DHL's Toronto station recently became the first in Canada to be credited as a Qualified Envirotainer Provider, as the logistics provider looks to move with an industry demanding greater levels of quality and greener credentials, using sustainable and reusable packing.

Brian Lindholm, chief executive of DHL Global Forwarding North America, said the accreditation marks the next step in the development of logistics services capable of offering the "excellent customer service this sector requires" – a demand which is only likely to rise in the future.

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