Customer focus: Pharma certification

posted on 3rd April 2018

Is IATA’s CEIV programme really what shippers want, and how does it compare with GDP? Megan Ramsay investigates

A recurring topic at air cargo conferences is the desire to develop and implement standards from within the logistics industry, in collaboration with shippers, rather than wait for requirements to be imposed by external authorities.

Indeed, in the absence of looming regulatory threats, regimes, or structures, the fragmented freight transport industry itself is often slow to deliver standardisation, quality, and modernisation initiatives. From online sales platforms, to air freight quality initiatives and digitalization programmes, the sector has struggled to achieve the critical mass needed to make genuine, tangible progress – or at least not as quickly as most would like.

But within the more highly regulated areas of air freight’s aviation environment, with its many safety and security requirements, the sector has been significantly more successful, particularly those areas under the responsibility of airlines themselves and representative bodies such as the International Air Transport Association (IATA) and ICAO.

Indeed, Andrea Gruber, senior manager for Special Cargo at IATA, says IATA “has a longstanding tradition of working closely with industry to develop standards that address their needs and ensure regulatory compliance and quality services”. And there is little doubt this is the case when it comes to areas such as safety, dangerous goods, and ULD handling, where clear standards and guidelines have long been developed and in place.

And so it was perhaps natural that IATA should leverage this experience in another area of key interest to air cargo carriers and the wider air freight sector that is also highly regulated – pharmaceuticals and healthcare products – even if those regulations apply mainly to the owners of the cargo rather than directly to transport companies and intermediaries. And the development of IATA’s CEIV Pharma programme was born out of another IATA initiative – to certify and set up a validation programme to meet the European Union (EU)’s ‘ACC3’ security rules introduced in 2014.

CEIV or GDP?

But there is some debate, disagreement, and even confusion within the air freight sector about whether the programme IATA has developed, supported, and created a certification programme for is really what shippers want and need – or whether cargo owners and their representatives they would actually prefer a certification standard more recognised by the pharmaceuticals and life science sector and its regulators, such as the EU’s Good Distribution Practice (GDP) or equivalent programmes.

So, what do pharma shippers really want?

IATA insists it has given the air freight sector and its customers the programme that carriers, shippers and their intermediaries needed – and asked for. To address the challenges in transporting and handling pharmaceuticals and healthcare products, IATA adopted a supply chain approach, Gruber explains. A dedicated working group, the IATA Time and Temperature Task Force (TTTF) was set up to develop new standards and recommendations. The TTTF is under the supervision of the IATA Live Animals and Perishables Board, a governance body comprised of 12 airline members. The board is responsible for endorsing healthcare standards for the air cargo industry as recommended by the TTTF.

The work undertaken by the healthcare industry subject matter experts in the Task Force – which is composed of shippers, freight forwarders, airlines, ground handling agents, international and national organisations, airports and equipment manufacturers – addresses temperature control management issues identified by the industry and sets out recommended standards, Gruber explains.

“These recommendations are then included in the IATA Temperature Control Regulations (TCR) – the industry standards that form the basis of the Center of Excellence for Independent Validators in Pharmaceutical Logistics (CEIV Pharma) programme and the checklist used in the framework of the certification programme. In a further effort to ensure a collaborative approach the checklist is shared with the shipper community to ensure their concerns are addressed and is enhanced based on their feedback.”

Logistics needs

So, what do shippers and their logistics representatives need – and think? Marken claims to be the only supply chain company in the world that is 100% dedicated to life science products. Dan Bell, vice president for quality, compliance and technical affairs, explains: “Most of our shipments are samples or drugs. We have a very specific focus, so all of our processes, procedures and the regulatory framework are focused around that.

“The items we transport have to be safe and efficacious to use when they reach the patient. That means keeping them stable in transit, controlling the temperatures they’re exposed to. GDP guidelines were developed to help keep that under control. EU GDP came in a few years ago – we need to have a compliant network.”

Failure to comply with GDP standards can result in restrictions on a business, fines, penalties, or even the distribution licence being revoked – not to mention the potential liability and patient safety issues that may arise.

Marken, a global company with 680 employees in about 45 locations and 10 depots, has its own in-house compliance programme that draws on elements of EU GDP, WHO and US Pharmacopeia guidelines. The company’s own facilities and local service providers must comply with that programme and are provided with appropriate training and equipment to help them achieve that.

Increasingly over the last five years, Marken has drawn employees directly from the pharmaceuticals business, such as the staff working on its quality programme – “people who really understand the needs of our clients”, Bell considers, highlighting the importance of sharing knowledge between hands-on logistics operatives and those responsible for standards.

Shipper perspectives

Certification related to GDP can be important to Johnson & Johnson, says Gino Vleugels, senior manager of temperature control for Customer & Logistics Services at the healthcare giant. “Each GDP-related certification programme has its own advantages and it’s up to the manufacturing companies, logistics service providers and airlines to decide which makes the most sense for their business needs,” he says.

And he includes IATA’s CEIV Pharma certification programme within these options. “If a company has IATA CEIV Pharma certification, the pharmaceutical shipper can be sure they are following the necessary training and that they’re being audited; we can trust that they are approved by an official institution against a global standard which is applied transparently and in a standard way at every location. This is a clear advantage compared to the commercial GDP certification available on the market.”

Vleugels stresses that certification should involve the logistics industry to draw on the expertise that relates to the shipments being transported, and here he also commends CEIV. “Brussels Airport and IATA actively involved pharmaceutical shippers in setting up the CEIV checklist and we have much more visibility of the results,” he says. “So, there’s a closer link between the CEIV certification programme and shippers than with the GDP programmes of the authorities.”

In addition, Vleugels believes GDP guidelines leave room for interpretation. “For example, when it comes to temperature control, some countries allow a risk-based approach while others require you to ship to label claim,” he explains.

“We prefer the risk-based approach because some products need to be stored in the 2-25°C range, but short exposures to temperatures from, for example, -20°C to +50°C during transit won’t affect their quality. So, shipping them to label claim can be an unnecessary expense.

“We know our products and the temperature ranges that are acceptable and we will never ship a product in conditions that can bring harm to a patient. Our reputation depends on it,” he concludes.

Airline preferences

But different airlines have different preferences in terms of GDP versus CEIV, including since the launch of CEIV. For example, Emirates SkyCargo’s new SkyPharma facility at its Dubai hub was awarded an EU GDP certificate of compliance for the transport and handling of medicinal products for human use by Bureau Veritas last year. When the facility was opened last September, Julian Sutch, manager of cargo global sales for pharma industry solutions at Emirates, noted that customers “want compliance with EU regulations”.

The carrier points out: “The Good Distribution Practice guidelines outlined by the European Commission have been designed to ensure that the quality and integrity of pharmaceutical products are maintained during transportation. As part of its audit process, Bureau Veritas, well known around the world for their high standards, subject knowledge and experience, scrutinised all aspects of the handling and storage of pharmaceutical shipments through Emirates SkyCargo’s dual hubs in Dubai to ensure compliance with GDP guidelines on a number of subjects including quality management, product integrity, security and training of staff handling pharmaceutical products.”

Finnair Cargo, meanwhile, was the first airline in the world to attain IATA’s CEIV Pharma certification (for its Brussels operations) in June 2015. And it has been followed by a number of other carriers.

Among the latest developments, US-based American Airlines Cargo is going for CEIV Pharma accreditation, saying: “With the increase in regulatory oversight of pharmaceutical logistics comes the industry-wide need to ensure quality handling from all stakeholders.” It said the scheme “impartially validates the capabilities associated with the proper transportation of delicate, temperature-controlled pharmaceutical shipments. In addition to the facilitation of critical training for warehouse handling staff on regulations and best practices, the certification includes the assessment and verification of properly equipped facilities, processes and operational effectiveness for the correct handling of these sensitive products.”

No single right answer

It seems, then, that there is no single right answer. Whichever certification a company chooses, Bell notes: “All regulations around the world have equivalents; there’s the World Health Organization guidelines, for instance, or the US Pharmacopeia 1083 (Good Distribution Practices – Supply Chain Integrity). In some places, such as the Middle East, the authorities need to see the actual temperature reading of a shipment before they release it, whereas in the US, data suffices,” he observes.

It is certainly true that the pharmaceutical industry is heavily regulated, and that more and more different countries are issuing their own regulations and guidance. Some countries, on the other hand, lack a GDP certification scheme – for instance, Germany regulates the pharmaceutical producers and wholesalers, but not the supply chain (which is audited by its customers).

According to Gruber, compliance, standardisation, accountability and transparency across the supply chain are definitely needed. This is why IATA developed CEIV Pharma: a standardised global certification programme training and assessing organisations against standards and regulations that encompass various regulations and standards – including IATA TCR, National GDPs and WHO, for instance.

“CEIV Pharma is one way to address industry’s concern, but what is more important to emphasise is that it was developed by the industry for the industry, with a greater focus on the operational aspect of the companies’ activities,” she stresses – something that members of the shipping community, like Johnson & Johnson’s Vleugels, certainly appreciate.

A step in the right direction

Bell agrees, describing CEIV as “a good step in the right direction”, even if it is perhaps targeted more at airlines than other stakeholders. “One of the biggest challenges is the multiple modes and nodes involved in clinical trials – that is, the multimodal transport required to get a product from door to door,” he notes. “The big gap five years ago was at the depots, but in-transit storage needs to be covered too. Getting airlines to look at their set-up and capabilities at different locations was the first challenge. Now, most airlines are committed to provide pharmaceutical or temperature-controlled services.”

IATA’s Perishable Cargo Regulations Chapter 17 (Air Transport Logistics for Time- and Temperature-Sensitive Healthcare Products) is among the guidelines in place. In addition, the EU’s GDP Annex 15 makes reference to transport – Section 6, Verification of Transportation – implying “audits of all modes and nodes”, Bell says. “Annex 15 will be a driver of change, as we all need to satisfy the requirements for a contingency plan in every risk assessment.”

Programme recognition

Nigel Connolly, director of technical operations at Marken, notes that it can take a long time for a programme to really establish itself. Currently, he says, the airlines “are not saying much – although CEIV has been well adopted in Northern Europe, for instance at Brussels airport. As for Marken, our own programme has high standards that comply with EU GDP; we have global SOPs and training in place to ensure that. Other programmes complement ours, but ours is very good.”

IATA, on the other hand, insists that feedback on CEIV from the industry is positive and that the scheme is expanding globally in response to a growing demand for standardisation and transparency.

“Stakeholders across the supply chain are now embarking on the programme,” Gruber observes. “They recognise the added value and benefit brought forward by the certified entities, such as being recognised as meeting the regulatory requirements as well as the standards in term of operations, adequate facilities and trained staff. Today, there are 50 companies that are certified and more than 70 that are in the progress of certification.”

In Gruber’s view, the best recognition of the effectiveness of a standard is its adoption by the industry, with ‘Pharma.Aero’ being one key example that unites all stakeholders. The Pharma.Aero initiative, which is closely linked to CEIV and brings together pharmaceutical shippers, airports, and logistics service providers, is a network allowing its members to collaborate, share and develop expertise in order to handle pharmaceutical products in the way shippers want it to be handled. The programme was launched in October 2016 by Brussels Airport and Miami International Airport.

Gathering momentum

So, CEIV Pharma appears to be gathering momentum as a means to encompass all the existing pharmaceutical transport guidelines and regulations under one umbrella. But there is still a great deal of support for certification programmes like EU GDP, and until CEIV Pharma attains critical mass it will remain one programme among many.

In the end, guidelines are there to help the people who are regulated to meet the requirements of the regulators – and they are open to interpretation. But most frameworks and guidelines, with a few exceptions, follow a very similar theme, observers note. They have the same ideas, although the language may differ and there are variations.

Distribution of pharmaceuticals is under intense scrutiny these days, though, so rules and regulations are likely to become tougher. So one challenge for IATA is to ensure CEIV Pharma keeps up to date with the latest regulations and standards, as well as keeping industry involved.

“We have to consider the compliance obligations of our clients as well as those relating to logistics and storage,” Bell adds. “For a long time, the regulators have been focused on the manufacturers (GMP – guidelines for how drugs are made and stored). Now, there is a greater focus on the supply chain (GDP – distribution).

“This is something that’s been increasing over the last three to five years. Next, I think we will see a greater focus on the last mile (delivery to the patient)” – particularly in light of the direct-to-patient services that have been pioneered in the last few years.