As the pharmaceutical and biotech industry gets more complex and the markets they serve become more diverse, the logistics involved in transporting these highly sensitive products gets more challenging. With changing regulations, strict temperature control and strong competition, it has become imperative for those involved in the pharmaceutical supply chain to consistently innovate and evolve to meet their clients’ needs.
Handling pharmaceutical products is a very complex, multi-tiered process, which requires compliance with strict requirements and procedures, while also adhering to specific shippers’ demands. An extremely lucrative business, pharmaceutical logistics is expected to be worth $86 billion in 2019. As it currently stands, only 0.5 million tonnes of pharmaceutical products are transported by air compared with 3.5 million tonnes using maritime trade lanes. Currently, the annual product losses associated with temperature excursions range from $2.5-$12.5 billion, a figure that IATA describes as “unacceptably high”.
Since the last couple of years, the air cargo industry has placed a special focus on pharmaceuticals – a growing and profitable sector. Since cold supply chains control and maintain temperature at each stage of a pharma product’s transhipment journey, the industry has begun developing new trends for various components of the cold supply chain, such as packaging, storage, transportation and distribution of pharmaceuticals, to ensure that the integrity of the product’s requisite temperature remains uncompromised. Innovative packaging techniques such as passive, active or semi-active packaging to maintain stable temperature of the pharma products during transit are also being used. To support the temperature-controlled logistics of pharma products, warehousing service providers are developing cold storage infrastructure for temporary storage of the pharma products. Apart from packaging and storing, cold supply chains are using refrigerated or reefer trucks to move pharma goods from the source of manufacturing and/or distribution centers to the end consumers while maintaining the products’ respective ambient temperatures.
Community initiatives for flying pharma
The main quality assurance challenge within the supply chain of pharma is mainly the fact of not having a thoroughly evaluated quality program and the lack of transparency, initiating a potential risk to the stability of the product itself and linked patient safety. The IATA CEIV pharma program has exactly pushed to have these quality standards. Meanwhile, initiatives like Pharma.Aero help in bringing shippers, airports and stakeholders in the supply chain around one table in order to take action and share best practices.
Explaining how the CEIV programme came into existence, Nathan De Valck, chairman of the industry-wide initiative Pharma.Aero recaps, “During pharma shipper workshops at the Brussels Airport, we listened to pharma shippers who wanted a more reliable and transparent handling service. Therefore, Brussels Airport took the initiative to build a quality improvement programme to align and standardise the pharma handling processes at the airport, involving all the stakeholders in the cold chain. The initial checklist was developed in collaboration with the shippers and based on the European GDP guidelines. After a proof of concept of the program with some local BRU cargo partners, we reached out to IATA in order to create a community certification program that would involve the global end-to-end pharma lanes, becoming the CEIV pharma program.”
As Valck puts it, more and more shippers underline harmonization of quality management systems, in order to close the “language gap” between two different industries, the high demanding pharmaceutical industry on one hand and of the multi-complex industry of airfreight logistics on the other hand.
Therefore, it is important that independent validation of the quality of logistical providers is available to guarantee a transparent and reliable process. “It is not about ‘forcing’ stakeholders; it is all about raising awareness. More and more shippers see Pharma.Aero as the forum in which different industries underline one vision, CEIV certification and validation. This collaboration platform will create opportunities to enlarge the common interest, to improve the standard practices and to implement continuous improvement policies,” said Valck. He further impressed upon the need for quality, the need for digitization and the need for sharing as the most critical points in the supply-chain.
“Through our participation in Pharma.Aero and the launch of Pharma@Changi initiative, Changi Airport Group aims to promote stronger collaboration across the supply chain. In recent years, there has been a growing demand for greater visibility in the transportation of pharma cargo. Live temperature monitoring as well as tracking of the pharma shipment’s location within the airport compound are some of the common requests from shippers. In response to these requests, Pharma.Aero has launched the “Certified Pharma lanes & Identification of Performance Indexes and Dashboard” initiative to provide greater transparency and reliability of the air cargo supply chain across the certified pharma lanes,” explains Lim Ching Kiat, managing director, air hub development, Changi Airport.
The initiative will also be evaluating prevailing technologies that can help digitise data and implement live temperature monitoring throughout the supply chain. Members of this initiative comprise of pharmaceutical shippers, airlines and airports. Another initiative is the Pharma.Aero Shippers Advisory Group, which gathers inputs from the pharmaceutical shippers to guide the air cargo industry towards improving the transport of pharmaceutical shipments by air, identifies key issues that shippers encounter and comes up with possible solutions to address these issues. “As pharmaceutical shippers and logistics players gain an appreciation of the benefits of working with IATA CEIV Pharma certified companies, we are seeing greater interest from shippers to either route their pharmaceutical cargo on IATA CEIV Pharma certified trade lane or give preference to companies which are CEIV Pharma-certified. For the year ahead, we look forward to strengthening our handling capabilities and pursuing growth opportunities with our partners to better serve the needs of pharma shippers,” Kiat added.
“Raising the level of quality performance has been at the forefront of the industry, covering such hot-button aspects as digitalization, transparency of information, and 100 per cent traceability at all stages of transportation. 24/7 monitoring of consignment condition and temperature status (both in the air and on the ground), access to each supply chain stakeholder ‘in one call’ – these are must have features and services for air cargo companies involved in the transportation of pharma products,” said Fedor Novikov - global director, Pharma, AirBridgeCargo Airlines.
AirBridgeCargo Airlines, one of the leading carriers for medical cargo, is upping its services in pharma transportation with its abcPharma product. The airline achieved IATA CEIV Pharma certification in 2016 and has since developed a number of special benefits for pharma customers, including the use of digital technologies to send automated notifications to all supply chain stakeholders via the Sky Fresh web platform, and supporting industry-level initiatives such as Pharma.Aero to generate a home-grown pool of logistics experts and orchestration of all internal handling procedures. These initiatives have helped ABC report significant increases in its volumes of temperature-sensitive pharma cargoes in 2017 as well as improved overall performance. In September 2017, AirBridgeCargo enhanced its pharma services further by gaining Envirotainer QEP accreditation at its global hub at Moscow Sheremetyevo Airport and in Dallas. In the following two months, ABC gained additional accreditations for its online stations in Milan, Frankfurt, Amsterdam, Los Angeles and Chicago.
Another important player in the transportation of pharmaceutical cargo, Emirates Skycargo, has been steadfast in offering customised transportation solution for temperature sensitive pharma. The carrier introduced Emirates Pharma, which caters to a variety of requirements from shippers and forwarders. “Since the launch of Emirates Pharma we have witnessed a strong growth in demand underlined by positive response from our customers. We continue to refine Emirates Pharma keep in line with evolution of customer needs,” said Julian Sutch, manager - global cargo development, Pharma, Emirates Skycargo.
Emirates SkyCargo operates the largest GDP certified multi-airport hub in Dubai and with its recent pharma corridors initiative, it is working with ground handlers at different stations to ensure a certified service for pharma cargo passing through these stations. The first 12 stations in Emirates SkyCargo’s pharma corridors are spread across three continents and include Amsterdam, Brussels, Bengaluru, Cairo, Dublin, Dusseldorf, Hong Kong, Luxembourg, Milan, Rome, Shanghai and Singapore.
“We constantly invest in developing technologies for better temperature protection on the ramp not just in Dubai but also across our network. The product development team at Emirates has developed the Emirates SkyCargo cool dollies. We have a fleet of 50 cool dollies dedicated for pharma in Dubai. Other developments include the White Container, of which we have a fleet of 120 containers and our White Cover thermal blankets. We work with all major container rental service providers to ensure that our customers have the widest choice of containers for their shipping requirements,” Sutch added. It has also developed the White CoverXtreme thermal blanket in partnership with DuPont which can guarantee robust protection for temperature sensitive pharmaceuticals under hot, weather and rainy weather conditions.
In a recent development, joint venture partners Virgin Atlantic Cargo and Delta Cargo opened a new Pharma Zone at their joint facility at London Heathrow Airport. The Pharma Zone is a fully-segregated area for handling and storing pharmaceutical shipments within a strictly-regulated temperature environment with active container storage. The area will support the temperature-controlled healthcare and life-science products being carried by both airlines.
Speaking about how Delta Cargo is contributing to make its pharma supply chain transparent and trustworthy, Julian Soell, managing director, operations & customer experience for cargo, Delta Air Lines said, “We has done so by achieving CEIV certification along with Delta’s self-handled global hub in Atlanta. Delta is the first US based cargo belly airline to achieve CEIV certification. Additionally several vendor handled stations have a mix of CEIV, GDP, WDA and QEP certifications and qualifications throughout Delta’s global pharma network. Delta has and continues to invest in the Pharma program which includes facility upgrades, training, policy and procedure, quality management and of course certifications so we can confidently support our customers who expect us to be accountable for their pharma shipments.”
Country-specific solutions that ensure regulatory compliance.
Amidst increasing regulatory focus on pharma products and their handling requirements, life sciences and healthcare companies are looking for cost efficient and country-specific solutions that ensure regulatory compliance. Shippers and freight forwarders are also becoming more vigilant while partnering with logistics companies and are choosing business partners who recognise pharma as special cargo instead of general cargo, and who provide tailor-made temperature-controlled handling solutions.
In India, for instance, the Food and Drug Administration (FDA) conducts audits on pharma manufacturing, shipping, warehousing and distribution facilities in order to check the quality standards of the drugs being shipped. Similarly, the Good Distribution Practices (GDP) certification ensures efficient transportation and handling of pharma products in line with WHO guidelines. IATA’s Center of Excellence for Independent Validators (CEIV) certification ensures the uniform implementation of best practices amongst all participants in the supply chain, thus minimizing the odds of a compromised pharma product.
“All organisations are working towards developing and improving their infrastructure in order to meet handling and quality requirements as expected by the certifying authorities. For instance, the AISATS COOLPORT and the AISATS Air Freight Terminal are GDP certified entities. The AISATS COOLPORT, which is India’s first integrated on-airport perishable cargo handling centre, has witnessed a 62 per cent increase in pharma cargo handling within the last year. This perishable handling centre also has an in-house Custom Clearance and Drug Controller Lab Testing facility, which reduces the cargo dwell time and facilitates faster cargo processing time,” reveals Mike Chew, CEO, AISATS.
All stakeholders in the pharma supply chain are making sure that the high-value and temperature-sensitive shipments are taken care of in the best possible manner. This includes ensuring that their staff and handlers are well-trained to handle such sensitive shipments. CEIV and GDP certifications are becoming increasingly important worldwide to prove that transport quality is high. And with client needs and expectations exceeding by the day – there is no possibility for an airport “blackhole”, no delays and no more temperature excursions. Shipment visibility and transparency is the key.