PHARMA LOGISTICS: A network approach

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IATA’s CEIV Pharma programme is evolving from certification of individual cargo handling stations towards certified trade lanes and networks, writes Will Waters

IATA’s certification initiative CEIV Pharma (Centre of Excellence for Independent Validators in Pharmaceutical Logistics) was launched almost two years ago as a voluntary globalised and standardised system to enable air freight companies to get their processes, infrastructure, and people assessed and validated in terms of their ability to transport and manage shipments of sensitive pharmaceutical products by air.

The objectives include the prevention of temperature excursions during transport, but also to improve handling and compliance with existing regulations and standards, supported by improving staff competences, through robust training programmes.

One of the key benefits was intended to be to disseminate standards within the industry and instill confidence and trust among pharmaceutical shippers in the air freight environment and provide a way for customers to identify and ensure reliable partners when it comes to transporting such a sensitive commodity – and in doing, so prevent further modal shift of pharma products from air to other modes.

Although the original expectation was to provide a certification process for air cargo handlers, it is increasingly being embraced across the air logistics chain – including by whole airport cargo communities and by carriers and forwarders across their networks. And IATA is now encouraging the creation of ‘certified trade lanes’ as the way forward, says Andrea Gruber, IATA’s senior manager for Special Cargo.

“We have been taking different approaches in order to ensure our ultimate goal is to have globally certified trade lanes, because one entity, one company at one airport doesn’t mean much,” she says. “Trade lanes or a network of certified companies is what is really important, and this is actually what shippers are expecting.”

SDV is pioneering the network approach, currently going through the process of certifying 12 to 15 stations worldwide, in partnership with IATA.

A community approach

Meanwhile, Brussels Airport has led the ‘community approach’, which has since been followed by Miami. And Madrid and Barcelona are also in the process of taking the CEIV community approach, Gruber says. “All of that is to ensure training to be certified from origin to destination. And even though the concentration so far has been on Europe, the intention and the objective is really global. It is not really at origin where the issue arises when it comes to transport of pharmaceutical products, but more at destination.”

As of December 2015, IATA had completed 18 certifications, with a further 45 in progress and 97 “in discussion”. Of those, Europe accounted for 17 of the 18 certifications completed – the other being the first certified company, Singapore ground handler SATS – and 28 of the 45 in progress. Asia accounted for a further seven certifications in progress, of which six are SDV facilities, and the seventh being PACTL at Shanghai Pudong airport. Rio de Janeiro’s Galeão International Airport (GIG) looks set to be the first in Latin America; Sharjah Aviation Services looks set to be the first in the Middle East; SDV’s O.R. Tambo facility in Johannesburg the first in Africa; and Miami is set to become the second CEIV airport community, with six of its stakeholders undertaking the certification process: CAS-USA; Centurion Cargo; LAN Cargo; Amerijet; Brinks; and Liason CAN/US Logistics.

How long it takes to undergo the process depends on the company. “There are different phases,” Gruber notes. The first stage is preparation, “when we get involved with the company to understand and define the scope of the certification, and define the activities they are performing, as the certification is for different types of stakeholders within the supply chain. Then the assessment will take between two and four days depending on how big the company is,” Gruber says.

“The assessment is based on a checklist that has been developed. We will look at all the findings and recommendations, and then we need to have those gaps closed before we can go for a validation process. It can take one or two months; it really depends on the company’s ability to close the gaps. We have experiences of seeing those gaps closed within four weeks, if they are minor gaps. Or it could take three to four months, depending on the issues that have been raised.

“So, it could take around four to six months, depending on the issues raised during the process.”

Globally certified trade lanes

When Gruber talks about globally certified trade lanes, what she means is “companies that are certified at origin and companies that are certified a destination, and it is this network that we consider as trade lanes. So when you have all of the whole chain certified, I think this is what makes sense.

“If you look even within an airport or even part of the activity, if you have only one ground handler that has been certified, all the stakeholders are interacting with each other, and I think what the expectations of the industry is to ensure that each other understands each and roles and responsibilities, and having everyone in the chain going through a certification – it might be CEIV or GDP, or a compliance certification depending on where you are in the world – this ensures that there are clear understandings and what is being expected for such a sensitive commodity.”

But IATA would not certify the whole chain, but would instead certify the individual components of the chain. “But it is quite interesting because when you start discussions with companies, they try to involve their partners as well, because it makes sense for them to ensure that if you go through the certification process, that your business partners go through it as well, in order to increase the levels of competency.”

Alignment with GDP

Gruber says that if a company already has GDP certification, it does not necessarily need to get that location CEIV certified.

“It depends where the company is,” she says. “For example, if you look at a European company and they are GDP certified and they want to certify their own station again within Europe, I would tend to say’ no’, they might only want to go with GDP certification. However, if you look at GDP and CEIV, CEIV encompasses not only the GDP requirements, but also IATA requirements, WHO requirements, or wherever we go it takes into account national requirements.

“When we started with SATS, we incorporated the Singaporean GDP – there are too actually there – into our checklists, into the process of assessment. Now, if a company within Europe wants to certified not only its station but also globally in its stations, it would make sense to go with CEIV.

“I think what is really important is the consistency globally, because even within Europe you have GDP requirements and EU guidelines that are actually implemented in different ways in different member states.”

The issue is complicated by the fact that GDP certification includes different types of certification – for example ‘wholesale distribution authorisation’, which is a level that IATA is not getting involved in.

Targets and expectations

Gruber says IATA has not put any target on how many certifications it hopes to achieve, but says: “We do it for and with the industry. But there are some interesting and big companies in the pipeline right now – it just needed one or two to get the process going.

“For me it is not about the quantitative aspect; it is the health and quality aspects, that companies can meet those expectations, is what is really important. But I hope there is more and more in order to spread this – and especially to meet the overall objective of having really those trade lanes certified.”

IATA’s global head of cargo, Glyn Hughes, comments: “What is really interesting to watch is that the people who are certified are the ones who are generating interest in certification elsewhere.” He particularly praises Brussels Airport for promoting the initiative.

“Brussels Airport does not look at this as a competitive advantage for Brussels Airport, but as a competitive advantage for air cargo. So they are speaking to whoever they can around the world,” Hughes says. “They are trying to get as many of their competitor airports as well as their partner airports, as well as all members of the supply chain, to look at certification – not just this road, but any road of certification, because collectively we really feel, and they feel – and they are great spokespeople for this – that we can actually arrest and reverse modal shift.”

Hughes concludes: “High-value, sensitive, patient safety-related commodities should not be spending 52 days sitting on a ship; they should be flying, going where they are needed as soon as they are needed.”