Pharma relies heavily on air freight to move its products around the world. Although GDP legislation applies equally across logistical modes, the structural complexity of flying presents particular challenges. Planes offer an obvious speed advantage for time-sensitive products, but this must be offset against issues such as multiple hand-off points, unique security risks, specific validation requirements, a notoriously exposed apron handling phase and a lack of uniformity in GDP implementation, all of which can impact on product integrity and safety.

The need to comply with differing and overlapping GDP standards is perhaps the most intractable of these downsides: achieving consistency across multiple legal jurisdictions and transit destinations can be a very difficult task, due to a huge spread of handling infrastructure, staff training levels and standards of control.

"CEIV Pharma is all about helping organisations to comply with existing regulations and brings a specific focus on the unique handling and storage circumstances that apply to air cargo transportation."

There is even a question of variability within the EU GDP itself. The latter has been made law through the system of EU Directives, by which a legal-enactment mechanism is conceived to accelerate the adoption of laws across all 28 member states. This means that, while guidelines are uniform and centralised, the implementation of them into national law is left to the individual countries. This opens up scope for national divergences in timing, interpretation and enforcement.

In addition, commercial certification bodies, sensing opportunity, are present in the certification space, adding to the confusion and duplication.

Bringing harmony

This is the scenario that IATA has stepped into, and means to address with its new CEIV Pharma certification programme. This initiative aims to harmonise GDP compliance and standardise audit formats by introducing a globally recognised pharma logistics and handling certification standard. Using independent trainers and expert auditors together with a universal audit format, the scheme has been designed to meet or exceed the worldwide regulations that are currently in force.

Andrea Gruber, IATA’s manager of cargo standards, first asked for comments on proposals for a new industry-wide auditing system at a conference in Luxembourg. The procedure was being designed to simplify and standardise the plethora of auditing and vetting processes that are springing up as pharmaceutical companies and freight forwarders scrambled to qualify their supply chains and meet the new GDP standards.

The IATA CEIV Pharma programme has now been successfully piloted, and is rapidly gaining acceptance as a universal, independent and comprehensive compliance and training scheme.

"The global nature of the pharma industry and its markets means that there needs to be a harmonised approach to distribution practices if costs and timescales are to be kept to a minimum, and the ultimate goal of greater patient safety achieved," says Gruber. "The goal is to build a network of IATA-certified trade lanes that have been independently assessed to a consistent and legally-compliant standard by qualified staff."

The CEIV Pharma programme is based around IATA’s existing CEIV (Centre of Excellence for Independent Validators), a network of independent, IATA-certified, auditors, and aims to provide a universally accepted auditing framework to ensure consistency of compliance. IATA will manage a database of validated locations and operators, as well as the necessary audit schedules and records.

Certain advantages

"The lack of a global GDP certification has been hampering the air freight sector’s attempts to capitalise on its inherent advantages as a preferred transportation medium for pharma products," affirms Rome-based cool chain consultant Marco del Giudice. "The IATA CEIV scheme avoids costly certification duplication and brings certainty to distribution quality control. It’s a big step forward for the pharmaceutical air-freight sector."

Del Giudice also points to the value of such a scheme when assembling pharma supply chains: "Shippers want a simpler certification system that allows them to find and compare different service providers and different cargo facilities from a common baseline. The CEIV Pharma programme provides a standardised benchmark from which to differentiate the best supply chain partners, services and facilities."

Some detractors claim that the IATA CEIV certification programme is just another qualification option that will further confuse the market and conflict with the World Health Organisation’s GDP recommendations. But according to Andrea Gruber, this belief represents a misunderstanding of the CEIV Pharma approach.

"The CEIV Pharma programme is not an alternative to the WHO GDP, the EU GDP or any other GDP," she explains, pointing out that the EU and other GDPs are generalised guidelines aimed at the entire freight sector and don’t take into account the specific circumstances of air freight.

"Instead, CEIV takes the binding requirements of the national and international GDP regulations that are already in place and harmonises these into a globally valid programme using air-freight-focused, on-site training and an integrated, yet independent, audit capability.

"CEIV Pharma is all about helping organisations to comply with existing regulations and brings a specific focus on the unique handling and storage circumstances that apply to air cargo transportation."

An initial pilot exercise was carried out with the Singapore Airport Terminal Services’ (SATS) perishables handling facility at Changi Airport in 2013. Since then, CEIV Pharma has been adopted by Brussels Airport, which became the first CEIV-certified ‘community’ in 2014. Schiphol is another major airport that is reported to be joining the programme on the same basis and other organisations are in the process of being assessed.

Community leaders

One of these is BCUBE Air Cargo, Italy’s largest air cargo handling and logistics company. Operating out of Milan, Rome and Venice, BCUBE is poised to become the first ground handling company in southern Europe to be IATA-CEIV certified for cold-chain pharmaceutical freight.

According to Mauro Grisafi, general manager at BCUBE, this certification is just the first phase in a continuous programme. "The next step will be the integration between qualified international pharma gateways," he reports. "It is important that pharmaceutical freight is shipped and managed in a standardised scenario through a worldwide logistics network that uses the same high level of quality procedures in a competitive context."

"It is important that pharmaceutical freight is shipped and managed in a standardised scenario through a worldwide logistics network that uses the same high level of quality procedures in a competitive context."

The long-term success of the IATA CEIV Pharma scheme is going to rest on its perceived relevance, its potential for saving money and the level of traction it can generate.

"I think the vast majority of entrants to the scheme aregoing to be ‘community groups’, says Steven Polmans, head of cargo at Brussels Airport. "If big companies, like Cargolux, or Kuhne & Nagel, bring in their supply chains, we will see a rapid uptake."

There is little doubt that the CEIV auditor network will serve to complement and reinforce the invariably stretched statutory compliance-enforcing resources. In their bid to reduce costs, compete with sea freight, guarantee standards and improve transparency, air shippers are seeking ever more efficient ways to navigate the regulatory labyrinth that governs the global distribution of healthcare products. To this end, the IATA CEIV Pharma initiative looks like a solution that deserves support.

Practice makes perfect

Distribution of temperature-controlled medicines is a tricky task, made more so by ever-increasing levels of global regulation. The EU’s Good Distribution Practices were approved in September 2013 and have increased the complexity of pharmaceutical transportation and forced the industry to adapt their cold chain.

IATA’s new CEIV in Pharmaceutical Handling aims to make air freight a more attractive transportation choice for pharmaceutical companies. The programme will assess an organisation’s cold chain processes and facilities and verify compliance will all applicable international standards and guidelines. These include the EU, WHO, and the United States Pharmacopeia.

Types of CEIV certification

There are two principal types of certification: Individual and Community. The latter involves the group-certification of a cluster. This would typically be an airport, and already Brussels Airport has pioneered this approach to become the first Community-certified location. Longer term, the idea is to create coalitions of these communities to provide interconnected global centres of excellence. Access to a global network of pre-qualified air-logistics providers, handling facilities and air-routes is expected to substantially raise standards and reduce regulatory compliance costs.

Five steps

The five steps towards IATA-CEIV certification are: preparation, assessment, validation, certification and ongoing training/continuous improvement. Mandatory recertification every two years will ensure that standards are maintained, and that the principles of sustained improvement and training are embedded within the receiving organisation.