Etihad Cargo continues strong cool chain product growth trajectory

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Managing Quality and Regulatory Risks in Pharmaceutical Technology Transfer

Technology transfer moves more than manufacturing instructions. It moves process knowledge, supplier dependencies, labeling requirements, packaging specifications, and the evidence needed to demonstrate control. For medical device manufacturers, including those supporting drug-device combination products, these interfaces can become recurring sources of compliance gaps during site transitions, acquisitions, and remediation. The central problem is often not a missing procedure. It is a quality system that allows connected activities to change independently. A label revision may be approved while packaging artwork, supplier instructions, or production-system data still reflect an obsolete version. Staying inspection-ready requires manufacturers to manage these dependencies as one controlled system. Why Compliance Gaps Keep Recurring Findings are treated as documentation defects Revising a procedure can resolve an immediate discrepancy without changing the behavior that caused it. If unclear decision rights, weak escalation, or ineffective training remain, the same failure may surface elsewhere. Corrective and preventive action should distinguish the observed finding from its underlying cause and establish how effectiveness will be demonstrated. Ownership is divided across connected functions Quality, Regulatory Affairs, labeling, packaging engineering, operations, suppliers, and digital-system owners often maintain separate workflows. Each team may complete its assigned task while an interface remains uncontrolled. For example, changing an instruction for use can affect packaging configuration, translations, technical documentation, inventory disposition, and release controls. Transitions expose unresolved weaknesses Acquisitions and site transfers can introduce conflicting procedures, incomplete knowledge transfer, or different assumptions about validated processes. Regulatory changes add further demands. When these events coincide with CAPA or change-control backlogs, teams may prioritize administrative closure over risk reduction. Without a coordinated impact assessment, local fixes can create new gaps downstream. Establish the Regulatory Baseline Inspection readiness starts with knowing which requirements apply to the product, activity, and market. Pharmaceutical, device, and combination-product obligations are not interchangeable; transfer planning should identify the applicable requirements rather than assume one quality framework covers every operation. According to FDA’s Quality Management System Regulation overview and FAQs, the QMSR became effective on February 2, 2026, incorporates ISO 13485:2016 by reference, and introduced the updated device inspection process under Compliance Program 7382.850. ISO 13485 certification does not exempt a manufacturer from FDA inspection or guarantee compliance with FDA requirements. For devices marketed in the European Union, Regulation (EU) 2017/745, Annex I, Section 23, provides the primary requirements for information supplied with devices, including labels and instructions for use. Teams should assess the applicable provisions alongside relevant language, product-specific, and market requirements. A labeling review should therefore evaluate required content and consistency with the device’s intended purpose and supporting documentation—not merely artwork accuracy. How to Identify the Real Gaps Begin with a cross-functional assessment that follows actual product and information flows. Select representative transfers, label changes, supplier changes, and CAPAs, then trace each from initiation through implementation and effectiveness review. Map dependencies: Identify affected specifications, suppliers, packaging components, systems, validation activities, and training. Compare records with practice: Check whether approved procedures match what operators and reviewers actually do. Test traceability: Follow a requirement through technical documentation, labeling, production instructions, and release evidence. Examine recurrence: Look for repeated deviations, reopened actions, overdue changes, and findings shared across sites. Assess capacity: Determine whether qualified owners have enough time and authority to complete corrective work. Prioritize gaps by potential patient or user harm, regulatory impact, likelihood of recurrence, and detectability. Document the rationale; an old overdue item is not automatically more important than a newly identified high-risk weakness. Align Quality, Labeling, Packaging, and Change Control Create a coordinated remediation plan with one accountable owner for each action, named contributors, acceptance criteria, and required evidence. Separate immediate containment from systemic correction. Containment might prevent obsolete labels from being issued; correction might redesign approval and implementation controls so obsolete versions cannot return. Use change control as the integration point. Before approval, evaluate effects on regulatory submissions or notifications, technical documentation, supplier controls, packaging performance, validation, electronic master data, inventory, and training. Record both identified impacts and justified decisions that particular activities are unaffected. During technology transfer, define readiness gates before production or release responsibilities move. These should address the transfer of process knowledge, acceptance criteria, receiving-site capability, required qualification or validation, approved documents, and personnel competence. The appropriate evidence depends on the product and process; a generic checklist cannot replace a documented assessment. Finally, verify implementation where the work happens. Confirm that current instructions are available, suppliers received approved requirements, systems contain correct versions, and affected personnel can perform their tasks. A signed approval is not evidence that every downstream change took effect. Mistakes That Undermine Inspection Readiness Closing CAPAs on task completion alone: Effectiveness checks should test whether the underlying failure has been controlled. Updating labels in isolation: Assess packaging, supplier, system, documentation, and inventory consequences. Counting closures instead of evidence: Dashboards need defensible records behind their status indicators. ...
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Etihad Cargo, the cargo and logistics arm of Etihad Airways, achieved year-on-year growth of the carrier’s dedicated cool chain products — PharmaLife and FreshForward — in 2023. The airline recorded the highest volumes of pharmaceuticals transported in Etihad Cargo’s history, achieving a 37 per cent increase in shipments compared to 2022. The carrier also transported 10 per cent more fresh and perishable shipments, making 2023 the third consecutive year Etihad Cargo has achieved growth for both products despite challenging market conditions. This milestone achievement reflects Etihad Cargo’s unwavering commitment to excellence in pharmaceutical and perishables logistics, reinforcing its position as a leading global air cargo operator.

Etihad Cargo has continuously invested in and added features to its cool chain product range, including PharmaLife for the shipment of pharmaceuticals, healthcare and life sciences commodities and FreshForward for the shipment of perishable fresh produce, including fresh fruits, vegetables, dairy, fish, meat and flowers. The carrier holds IATA’s Centre of Excellence for Independent Validators (CEIV) certification in Pharmaceutical and Fresh logistics. A consistent commitment to safety and quality has enabled Etihad Cargo to achieve a 99.1 per cent compliance rate for pharmaceutical shipments in addition to growing cool chain volumes for the last three years.

Contributing to the increase in cool chain volumes transported by Etihad Cargo in 2023 was the opening of the carrier’s dedicated pharma hub, which has doubled its cool chain storage and handling capacity. The 3,300 square-metre facility comprises the latest technology and features, including RFS loading docks with levellers, insulation and floor work for faster and more efficient loading with stricter temperature controls, increased storage space, additional build-up and breakdown zones for improved production workflows and upgraded cool chain facilities for our pharma handling and storage operations. Since launching the new pharmaceutical centre in July 2023, Etihad Cargo immediately achieved an increase in pharmaceutical volumes, recording a 39 per cent increase in July, a 40 per cent increase in August and a 41 per cent increase in September.

Etihad Cargo has also refurbished its perishables handling and storage facility. The carrier operates a 3,000-square-metre dedicated perishables temperature-controlled warehouse, providing smoother transfers to Etihad Cargo’s FreshForward truck fleet, making the end-to-end journey of perishables easier and safer.

Leonard Rodrigues, Acting Managing Director at Etihad Cargo, said: “Etihad Cargo is fully aligned with Abu Dhabi’s vision of becoming a global logistics, pharmaceuticals and perishables hub. The carrier’s commitment to quality combined with continuous product and infrastructure enhancements has enabled Etihad Cargo to achieve significant growth and contribute to the creation of a more resilient and robust global cool chain.”

Expanding beyond the carrier’s Abu Dhabi hub, Etihad Cargo’s PharmaLife network covers over 62 destinations. To strengthen connections between Abu Dhabi and the rest of the world, Etihad Cargo has developed over 1,330 IATA CEIV Pharma/ Good Distribution Practice (GDP)-certified trade lanes, ensuring product integrity. Etihad Cargo is actively collaborating with key airline partners to establish further IATA CEIV-certified pharma trade lanes to broaden the carrier’s network through dedicated PharmaLife agreements.

Since launching Pharma Corridor 2.0 between Abu Dhabi and Brussels, Etihad Cargo has provided the highest levels of assurance in the quality of handling to pharmaceutical shippers and forwarders through the establishment of pharma corridors between airports with cargo handling communities certified under the IATA CEIV Pharma programme. In 2023, the carrier recorded a 10.3 per cent increase in volumes transported via the first-of-its-kind corridor and has shipped over 70 per cent more pharmaceutical and life sciences cargo volumes since the corridor’s creation. The consistent growth for the Abu Dhabi to Brussels lane has been a major contributing factor to Etihad Cargo achieving the highest recorded PharmaLife tonnage since the carrier’s inception.

Rodrigues said: “The establishment of Pharma Corridor 2.0 and an expansive global PharmaLife network has enabled Etihad Cargo to bring much-needed transparency, traceability and trackability to the sector, benefiting not only customers but also the global pharma supply chain. The unique collaboration and partnerships Etihad Cargo has pioneered have allowed the carrier to offer complete transparency on the status of temperature-controlled pharmaceutical shipments, recording quality, time, temperature, potential deviations and actions. Etihad Cargo is now actively exploring further opportunities to create additional corridors between Abu Dhabi and other key markets to bring these benefits to more regions critical to the manufacture and supply of pharmaceuticals. Leveraging the success of the Pharma Corridor, Etihad Cargo has launched Fresh Corridor 2.0 between Abu Dhabi and the Netherlands, resulting in a 42 per cent increase in fresh volumes transported.”

Etihad Cargo has also provided additional cool chain capacity to its partners and customers with the addition of new stations and increased frequencies to its global network, which has grown to serve over 70 destinations. Etihad Cargo’s expanding freighter network, in combination with the airline’s passenger network, supports growing capacity demand for Etihad Cargo’s premium products, including PharmaLife and FreshForward. In Asia, the carrier added a fourth gateway destination in China — Ezhou — in 2023 and offers more belly hold cargo capacity across new passenger routes to Kozhikode and Thiruvananthapuram, operating seven flights per week to each destination. Seven new passenger flights to Chennai bring the total number of weekly flights to 21, supported by a twice-weekly freighter service.

Rodrigues concluded: “Etihad Cargo’s partners have benefited from the carrier’s expanded operations in key regions and increased frequencies across critical trade routes for pharmaceutical and perishables flows. For example, India represents 30-40 per cent of the global production of generic medications and supplies medicines to over 200 countries. The country is establishing itself as a healthcare hub, which is driving demand for PharmaLife, and Etihad Cargo is committed to supporting emerging and growing markets through new product features, technology and dedicated expertise. In 2023, Etihad Cargo started new pharma roadshows and naturally focused on India. The carrier’s Pharma Champions programme is providing local expertise for Etihad Cargo’s Indian customers as well as enhancing its connectivity to India’s key markets, including North America and Europe. In less than one year, Etihad Cargo has doubled its PharmaLife volumes ex India.”

Etihad Cargo recently announced it will be implementing enhanced cargo screening requirements for US-bound shipments from selected stations, including Mumbai, Bangalore, Delhi and Hyderabad, and Bangkok, Jakarta, Hanoi, Kuala Lumpur, Manila and Singapore. The enhanced cargo screening requirements will benefit Etihad Cargo’s partners and customers through shorter transit times in Abu Dhabi, reduced handling and repackaging at transit points, and quick ramp transfer (QRT) and through units (TRU) shipments. Cargo originating from Australia, China, the European Union, Israel, Japan, South Africa, South Korea and the United Kingdom to the US will also benefit from the enhanced screening requirements.

 

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Managing Quality and Regulatory Risks in Pharmaceutical Technology Transfer

Technology transfer moves more than manufacturing instructions. It moves process knowledge, supplier dependencies, labeling requirements, packaging specifications, and the evidence needed to demonstrate control. For medical device manufacturers, including those supporting drug-device combination products, these interfaces can become recurring sources of compliance gaps during site transitions, acquisitions, and remediation. The central problem is often not a missing procedure. It is a quality system that allows connected activities to change independently. A label revision may be approved while packaging artwork, supplier instructions, or production-system data still reflect an obsolete version. Staying inspection-ready requires manufacturers to manage these dependencies as one controlled system. Why Compliance Gaps Keep Recurring Findings are treated as documentation defects Revising a procedure can resolve an immediate discrepancy without changing the behavior that caused it. If unclear decision rights, weak escalation, or ineffective training remain, the same failure may surface elsewhere. Corrective and preventive action should distinguish the observed finding from its underlying cause and establish how effectiveness will be demonstrated. Ownership is divided across connected functions Quality, Regulatory Affairs, labeling, packaging engineering, operations, suppliers, and digital-system owners often maintain separate workflows. Each team may complete its assigned task while an interface remains uncontrolled. For example, changing an instruction for use can affect packaging configuration, translations, technical documentation, inventory disposition, and release controls. Transitions expose unresolved weaknesses Acquisitions and site transfers can introduce conflicting procedures, incomplete knowledge transfer, or different assumptions about validated processes. Regulatory changes add further demands. When these events coincide with CAPA or change-control backlogs, teams may prioritize administrative closure over risk reduction. Without a coordinated impact assessment, local fixes can create new gaps downstream. Establish the Regulatory Baseline Inspection readiness starts with knowing which requirements apply to the product, activity, and market. Pharmaceutical, device, and combination-product obligations are not interchangeable; transfer planning should identify the applicable requirements rather than assume one quality framework covers every operation. According to FDA’s Quality Management System Regulation overview and FAQs, the QMSR became effective on February 2, 2026, incorporates ISO 13485:2016 by reference, and introduced the updated device inspection process under Compliance Program 7382.850. ISO 13485 certification does not exempt a manufacturer from FDA inspection or guarantee compliance with FDA requirements. For devices marketed in the European Union, Regulation (EU) 2017/745, Annex I, Section 23, provides the primary requirements for information supplied with devices, including labels and instructions for use. Teams should assess the applicable provisions alongside relevant language, product-specific, and market requirements. A labeling review should therefore evaluate required content and consistency with the device’s intended purpose and supporting documentation—not merely artwork accuracy. How to Identify the Real Gaps Begin with a cross-functional assessment that follows actual product and information flows. Select representative transfers, label changes, supplier changes, and CAPAs, then trace each from initiation through implementation and effectiveness review. Map dependencies: Identify affected specifications, suppliers, packaging components, systems, validation activities, and training. Compare records with practice: Check whether approved procedures match what operators and reviewers actually do. Test traceability: Follow a requirement through technical documentation, labeling, production instructions, and release evidence. Examine recurrence: Look for repeated deviations, reopened actions, overdue changes, and findings shared across sites. Assess capacity: Determine whether qualified owners have enough time and authority to complete corrective work. Prioritize gaps by potential patient or user harm, regulatory impact, likelihood of recurrence, and detectability. Document the rationale; an old overdue item is not automatically more important than a newly identified high-risk weakness. Align Quality, Labeling, Packaging, and Change Control Create a coordinated remediation plan with one accountable owner for each action, named contributors, acceptance criteria, and required evidence. Separate immediate containment from systemic correction. Containment might prevent obsolete labels from being issued; correction might redesign approval and implementation controls so obsolete versions cannot return. Use change control as the integration point. Before approval, evaluate effects on regulatory submissions or notifications, technical documentation, supplier controls, packaging performance, validation, electronic master data, inventory, and training. Record both identified impacts and justified decisions that particular activities are unaffected. During technology transfer, define readiness gates before production or release responsibilities move. These should address the transfer of process knowledge, acceptance criteria, receiving-site capability, required qualification or validation, approved documents, and personnel competence. The appropriate evidence depends on the product and process; a generic checklist cannot replace a documented assessment. Finally, verify implementation where the work happens. Confirm that current instructions are available, suppliers received approved requirements, systems contain correct versions, and affected personnel can perform their tasks. A signed approval is not evidence that every downstream change took effect. Mistakes That Undermine Inspection Readiness Closing CAPAs on task completion alone: Effectiveness checks should test whether the underlying failure has been controlled. Updating labels in isolation: Assess packaging, supplier, system, documentation, and inventory consequences. Counting closures instead of evidence: Dashboards need defensible records behind their status indicators. ...

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