GDP doubts over airline certification
15 / 12 / 2015
Airlines cannot be certificated for Good Distribution Practice (GDP) along the entire supply chain for pharmaceutical transport but can still be compliant to GDP standards.
Annette Kreuziger of Lufthansa Cargo told a pharma conference in London that “it is not just possible” for airlines to assess all the varied third party operators in the global supply chain in order to gain GDP certification, the European Union regulator benchmark.
Kreuziger, director product and solutions management specials and express at the German carrier, said that Lufthansa has identified a number of ‘red label’ areas where airlines have no “control at all” in the GDP process and so making it impossible to go for GDP.
The carrier has also identified yellow areas, where it is possible for an airline to have influence and green ones which it “can absolutely fulfil”.
But Lufthansa has already become GDP certificated at its cool chain centre in Frankfurt and is setting up a database of its cargo station network which will detail the cool chain capabilities of up to 300 hubs worldwide.
Given the capability at each station, a shipper or forwarder may decide on a different kind of packaging, for example, to mitigate any pharma supply chain risk.
Kreuziger said that the pharma and airline industries have a lot in common, because they operate in a heavily regulated environment where safety and security are paramount.
“Where we meet is when materials have to be managed with temperature and time controls, which is a tricky interface and an interface that everyone wants to regulate,” citing 35 different documents worldwide, be they laws or guidance papers, relating to pharma transport.
“As an airline we cannot be GDP certificated but we are GDP compliant.”
As her ‘wish list for the future,’ Kreuziger called for a worldwide certificated standard for the air cargo transport of pharma goods.
She was speaking at the Air Cargo News’ Life Science and Pharmaceuticals conference which had earlier heard from Cheryl Blake, a GDP inspector at the UK’s MHRA, who gave an overview of the complex regulatory environment around the safe and secure transportation of pharma goods.
The UK inspectorate made 532 visits in the first six months of this year, which had highlighted a number of issues, including “inappropriate validation” of key equipment or processes, the use of unauthorised premises for holding pharma goods and a lack of temperature mapping in cold stores and other locations.
She gave the example of one air cargo forwarder who had met all of the regulations and had exemplary process for handling pharma goods but who put the wrong IATA temperature control label on the goods, in front of the inspector.
One audience member, with a Middle East carrier, said that his station had been audited five times in the past year, by three forwarders and two shippers, who were satisfied that his pharma handling was compliant with GDP, “but not one of them asked for a certificate”.
Another example from the floor said that a pharma shipper on a new route from Amsterdam to Sydney had first checked with cargo handlers at the Australian airport was GDP compliant, and then looked at the airline customers of that particular handler and then did the same for Amsterdam, basing the final supply chain decision on that process.
It was also stated from the audience that in certain parts of Africa and the Indian subcontinent, where state-owned handlers have a monopoly, that it can be “quite hard” to push for GDP standards in handling pharma goods.