Transporting pharmaceuticals is big business, set to be worth $86 billion in 2019, $15 billion of which will relate to cold-chain products.
But aviation risks not getting its fair share of the market. As it stands, only 0.5 million tons of pharmaceutical products are transported by air compared with 3.5 million tons using maritime trade lanes.
The main reason for this discrepancy is the lack of trust in the aviation value chain’s handling of vaccines and medicines.
When differing standards are used by the various participants in the supply chain, the integrity of pharma shipments can be compromised
It is estimated that 25% of vaccines degrade by the time they reach their destination, with temperature excursions attributable to airline and airports above 50%.
The issue is the lack of global certification standards that are internationally recognized and implemented, says Ronald Schaefer, IATA’s Assistant Director, Cargo, Ground Operations and CEIV Consulting.
“When differing standards are used by the various participants in the supply chain, the integrity of pharma shipments can be compromised, resulting not only in the loss of potential lifesaving products but also in the loss of trust in the pharmaceutical handling supply chain itself,” he says.
IATA’s Center of Excellence for Independent Validators (CEIV Pharma) aims to resolve the problem, creating a network of globally-certified trade lanes.
CEIV Pharma sets global standards and regulations, and ensures compliance through a process of independent validation. The result is quality services delivered in a harmonized and globally-consistent manner.
Companies that achieve CEIV certification have seen a rise in the quality of the delivery of their pharma handling services
Program components are updated on a yearly basis and training echoes the latest industry best practices.
“The comprehensive 290-plus point checklist covering everything from Quality Management System documentation to on-ramp handling activities is also updated to reflect the latest technologies as well as industry and regulatory requirements,” informs Schaefer.
CEIV Pharma certification is becoming globally recognized by the pharmaceutical industry.
“Companies that achieve CEIV certification have seen a rise in the quality of the delivery of their pharma handling services, which is a direct benefit to their customers,” says Schaefer.
“Even if only one station is certified, the knowledge gained from the training courses and a gap analysis report and implementation plan always provides benefits.”
The pharmaceutical industry backs up these claims. Manufacturers see standardization, certification, and transparency across the supply chain as a necessary step forward for aviation.
Johnson & Johnson Logistics Manager, Gino Vleugels, says the company “fully appreciates the commitment IATA has demonstrated” in looking to set industry standards in this area.
“We look forward to working closely with IATA in further enhancing the CEIV Pharma program and promoting the program to ensure its worldwide adoption,” he adds.
The European Shippers Council, Merck Sharp and Dohme (MSD) Asia Pacific, Baxter, and Zoetis are among the many other manufacturers that endorse CEIV Pharma.
CEIV Pharma certification applies not only to airlines and airports but also to all supply chain partners. The program is expanding rapidly.
In July 2017, Amerijet became the first US all-cargo airline to earn IATA’s CEIV Pharma certification.
“As an airline, our role in the supply chain is to provide safe handling for all pharmaceutical shipments and we demand the same standards from our business partners, including our customers,” says Pamela Rollins, Senior Vice President of Business Development at Amerijet.
“Data tracking from transport start to finish has become indispensable for temperature-sensitive drug product integrity. Amerijet is aiming for full transparency in the supply chain.”
To meet CEIV Pharma’s exacting standards, Amerijet has invested heavily across the board.
There has been a rapid growth in the establishment of CEIV Pharma communities
At Miami International Airport, for example, there is new custom-built cooling facility equipped with active alarm systems, temperature data recorders and 24/7 CCTV monitoring.
Meanwhile, there has been a rapid growth in the establishment of CEIV Pharma communities—groups of stakeholders centered on an airport hub or a particular supply chain that decide to undergo CEIV Pharma certification together.
Forwarders, handlers, truckers, and airlines all participate, as long as they are committed to providing quality pharmaceutical handling services.
Although pharma shippers and regulators cannot be certified, they can participate as observers and even attend training sessions to get a better understanding of the CEIV Pharma program.
Brussels Airport was the first to go down this route. It invited a group of ten local stakeholders to undergo CEIV Pharma training to assure cold-chain integrity to their clients.
Steven Polmans, Head of Cargo, Brussels Airport says the strength of CEIV Pharma lies in the fact the criteria were set by the shippers and “ignoring this program is ignoring the interests of the pharmaceutical industry.”
To date, 12 communities have taken this approach and an additional nine airports are in the process of creating their own community. Beyond providing clients with global best practice in the community’s handling of pharma products, the community idea allows stakeholders to share information and understand each other’s requirements. This furnishes even greater efficiency among the participants.
Looking ahead, CEIV Pharma will be promoted in regions where it has not yet made strong inroads, such as Africa.
The plan also calls for strengthening the relationship with pharma shippers and increasing the database content available to better facilitate trade lane evaluations.
CEIV raised the bar of our performance, encouraging our customers’ level of credibility and increasing our volumes
“It has been a year since AirBridgeCargo Airlines gained IATA CEIV and we were able to demonstrate our ability to protect the quality, integrity and consistency of temperature-sensitive pharma products,” concludes Fedor Novikov, Pharma Director, Global, AirBridgeCargo Airlines.
“Being perceived as an industry benchmark, CEIV raised the bar of our performance, encouraging our customers’ level of credibility and increasing our volumes, which constitutes 3% of total cargo carried for nine months of 2017,” he adds.
“That is a significant twofold increase as a confirmation of our competency and expertise in the pharma sector.”
How does CEIV Pharma work?
The CEIV Pharma certification process varies from one organization to another but, based on experience, implementation takes on average six-to-seven months.
The process begins with the training component. This consists of two multiple-day courses that cover a variety of topics regarding temperature-controlled cargo operations as well as the audit, quality and risk management of temperature- controlled cargo.
An assessment of an entity’s cool chain/pharmaceutical processes and facilities against international standards, guidelines and regulations follows.
Recertification takes place every three years and includes an assessment as well as one refresher training course
Prior to the assessment, the comprehensive CEIV Pharma Audit Checklist is provided so an organization can self-determine any potential gaps before the Independent Validator’s (IV) onsite visit. The resultant gap analysis report identifies the critical elements in non-compliance with national and international regulations.
An appropriate implementation plan to close the gaps and meet CEIV Pharma requirements is the end result of the assessment.
The final stage of certification, the validation phase, ensures any shortcomings have been rectified.
During the validation, IATA’s independent validators go through the checklist one more time and at the end recommend whether all requirements have been fulfilled and an entity can be “CEIV Pharma Certified”.
The process, however, does not end with certification.
Recertification takes place every three years and includes an assessment as well as one refresher training course, plus a validation if necessary.
This ensures that program participants maintain their high standards in transporting pharmaceutical products and are able to adjust to new best practices for years to come.