Until recently the pharmaceutical industry viewed air transport as a mysterious process, without rigorous standards to guarantee the right conditions for shipping temperature-sensitive products. The Good Distribution Practice (GDP) Guidelines and Center of Excellence for Independent Validators (CEIV) Pharma have changed this view.
Addressing the issue with new guidelines and validators
After a six percentage-point drop in the global share of air pharma cargo transport between 2000 and 2013, the IATA addressed the issue. They established new guidelines to ensure transparency and proper conditions for pharma air shipments. These protocols - the Center of Excellence for Independent Validators (CEIV) Pharma - set out specific and clear standards for handling air freight shipments of pharmaceutical goods. CEIV Pharma delivers worldwide consistency and goes well beyond the transport and storage requirements as mentioned in the Good Distribution Practice (GDP) Guidelines.
The limitations of the GDP guidelines
'We have been GDP certified since 2013', says John Twisk, Director of Operations for CyberFreight International. 'We needed to invest in dedicated and conditioned warehouse facilities with dedicated and trained staff. But we didn't stop there. We also document and control all processes continuously. Because once certified, we always need to be in compliance with the guidelines. GDP authorities can visit us at any time, without warning. Building the infrastructure and putting these polices into place created a positive impact on our organisation.'
GDP guidelines address many of the initial supply chain needs of European pharmaceutical manufacturers and wholesalers. However, it is not detailed enough on how to properly handle pharmaceutical products at each point in the supply chain, nor does it cover the actions needed to limit any risks. 'Even though GDP is the standard required by the pharmaceutical industry to govern the movement of their specific products, we were not satisfied with GDP alone. These guidelines can be applied differently in each country and they do not contain specific guidelines or requirements for transport. Especially for air freight, which has a very complex supply chain, involving multiple parties. This complexity calls for global standardisation of air freight movements of pharmaceuticals. So we were delighted to learn about the CEIV Pharma IATA Program’, Twisk continues.
Moving up to CEIV to go beyond the standards Pharma demands
CEIV provides more stringent regulations than GDP regarding both the temporary storage and transport of pharmaceutical goods. It spells out what each party must do to be in compliance with the regulations. It, for example, explains the actions and responsibilities of agents, transporters and even booth handlers. It also defines how transport must be handled on airside. And it states exactly how to use all components needed to store and transport pharmaceutical goods. Furthermore, the regulations describe other requirements to ensure that everyone within the supply chain knows that the containers contain extremely perishable, pharmaceutical products and how to protect them.
Twisk says: 'CEIV offers a more comprehensive assessment and validation for logistic providers than GDP does. The CEIV assessors and validators appear to be people with experience in the logistics industry. GDP assessors, on the other hand, don’t have this level of logistics experience, as GDP is not specifically meant for logistic providers. The GDP validators’ expertise covers important subjects, but they are not necessarily relevant to air transport. It is more difficult to earn a CEIV Pharma-certificate. We have to be able to say 'yes' to nearly 300 questions.'
Ensuring the correct handling of pharmaceutical goods
The universal audit format in CEIV has been designed to meet or exceed the worldwide regulations that are currently in force. By increasing the speed of transport of temperature-sensitive pharmaceuticals in a safe and controlled environment, CEIV helps eliminate spoilage of highly perishable pharmaceutical cargoes. Other benefits include avoiding the costly claims against forwarders and airlines as well as ensuring higher quality public health due to the increased availability of medicines.
With GDP and CEIV combined, pharmaceutical companies can now rely on a fast, convenient and transparent cold chain logistics system, that air transport allows. 'All of these quality systems are related to each other', says Arie in 't Veld, QA Manager at CyberFreight International. 'My priority is to make sure that all the right procedures are in place, effective and connected to each other.'
Building a pharma logistics community around Schiphol
Pharma Gateway Amsterdam (PGA) consists of 13 members. These companies are located at or near Amsterdam Airport Schiphol, Europe’s third largest cargo gateway. The PGA members meet on a regular basis. By enabling close cooperation between all parties—airlines, ground handlers, freight forwarders, and trucking companies—PGA fosters the transfer of Pharma logistics knowledge and expertise among its members.
'Amsterdam Airport Schiphol is working hard to make a difference', says Twisk, 'within the PGA, we discuss CEIV and GDP regulations and compliance and matters of concern. Goal is to come up with new ideas and to establish procedures that address the logistics and transport needs of the pharmaceutical industry. Not only does this make us better as separate companies, but it makes Amsterdam Airport Schiphol, as a community, more vibrant. And most importantly, this helps Schiphol improve the experience and service that our Pharma customers receive.'