Pharmaceutical freight hub certification. How to obtain certification from IATA as capable of handling temperature sensitive pharmaceuticals. Air Cargo has faced a decline in trust from the pharmaceutical industry.
Up to 25% of pharmaceuticals reach their destination with degraded potency due to temperature excursions during transport
30% of all scrapped pharmaceuticals are the result of logistics issues
20% of all temperature-sensitive products are damaged due to broken cold chains.
This has the potential to affect the lucrative deals that cold-chain transportation for the pharmaceuticals industry bring.
The aim of the logistics industry is to reduce the number of pharmaceutical temperature excursions that result from the broken cold chain. Although individual countries have standards, regulations and guidance there is lacking a universal, global certification for the transport and handling of pharmaceutical products.
In order to combat this, the International Air Transport Association (IATA) set up the Center of Excellence for Independent Validators in Pharmaceutical Logistics (CEIV Pharma). This organisations vision is to support the cold-chain air freight pharmaceutical logistics providers worldwide, improve standards, and regain trust from the Biopharma industry that air freight can be relied upon to deliver a quality product.
How to be CEIV Certified?
The first step is to perform an assessment on the cargo companies current practices and pharmaceutical handling procedures. These are checked against the current international best practices, standards and regulations. The result of this assessment will highlight any gaps in the current procedures. This forms the basis of the action plan that the cargo provider needs to comply with before undergoing certification.
Once all the standards are met, there is a mandatory two-day training course where topics covered include the handling and transport of temperature-sensitive pharmaceutical products. After this, a final phase is entered where the systems in place are validated and assessors recommend if the company is in compliance and can be called “CEIV Pharma Certified”.
Miami International Airport
in 2015 Miami International Airport (MIA) was certified as the first CEIV Pharma hub in the USA, and only the second in the world. In the Western Hemisphere they also have unparalleled storage capacity with 451,885 sq/ft (41,981 sq/m) of refrigerated storage facilities within the airport hub. MIA engaged it’s cargo handling partners in the CEIV program, and by 2017 had a total of 6 companies where were all CEIV Pharma Certified.
Swissport Cargo Services
Swissport Cargo Services currently operate six CEIV Pharma Certified facilities across their network.
The IATA CEIV Pharma Certified program was very detailed, so there was a lot of upfront learning for us, from which our customers will reap great benefitsNils Knudsen, Chief Commercial Officer of Swissport International
The Swissport Cargo Hub at Basel is of prime importance. It is at the centre of a significant pharmaceutical cluster and up to 30% of the 50,000t of annual exports from the Basel hub are temperature-sensitive pharmaceutical products. They have special cooling units for storage at temperatures of 2°C to 8°C (35°F to 46°F) and -20°C (-4°F). Swissport has direct access to the tarmac at the airport which allows for the movement of pharmaceutical products from the temperature-controlled warehouses to the aircraft within an average of 2 minutes.
“The risk assessments for CEIV Pharma are even stricter and more fundamental. They focus on operational risk, which obviously leads to a different evaluation of certain processes and procedures. The IATA CEIV Pharma process is very detailed so there was a lot of upfront learning for us from which our customers will reap great benefits.”Nils Knudsen, Chief Commercial Officer of Swissport International
Swissport is not the only cargo carrier who are taking CEIV Pharma Certification seriously. Lufthansa Cargo, DHL Global Freight Forwarding, Brussels airport (the first CEIV Parma hub in the world) and more. The video below includes testimonials from these carriers.
The Future of Pharma Air Freight
As the regulatory requirements from the FDA in the US and the European Medicine Agency become more stringent there is a need for the businesses involved with the handling and transportation of temperature-sensitive pharmaceuticals to also be in compliance. A violation of the regulatory requirements can seriously tarnish a companies reputation. It can result in costly fines and lost clients. It is essential therefore that if you operate as an air freight logistics company who handle pharmaceutical products you are aware of, and in compliance with, the relevant standards. Obtaining CEIV Pharma Certification will help to ensure that you meet the obligations.
Many airport hubs around the world that operate major freight terminals are joining the program, with their logistics partners obtaining certification. CEIV Pharma certification. If you operate an air cargo service and want to be taken seriously by the Biopharma industry, you better make sure you have it!