Big changes are afoot in the Pharma freight sector as it adapts to market, regulatory and technological trends. Alan Kennedy reports on the problem of divergent GDP guidelines, and hears from IATA’s Andrea Gruber about the organisation’s programme, which attempts to bring order to the table.

Pharma relies heavily on air freight to move its products around the world. Although GDP legislation applies equally across logistical modes, the structure 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.

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.

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.

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”

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.

Andrea Gruber

Andrea Gruber is manager of cargo business, process and standards for the IATA. Previous roles include senior manager, specialised cargo, at IATA, and business, process and standards manager at IDFS Cargo.

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