Pharma Company Maintains GDP Compliance on Spain–Italy Cold Chain Route

A mid-sized pharmaceutical distributor based in Valencia specialises in temperature-sensitive biologic products and diagnostic reagents, supplying hospitals and laboratories across Northern Italy. Their product portfolio requires strict cold chain management between 2°C and 8°C from warehouse to warehouse, with full regulatory traceability mandated under EU Good Distribution Practice (GDP) guidelines.

The Challenge

The distributor's supply chain team had been managing the Spain–Italy corridor with a combination of air freight and ad-hoc refrigerated road transport, creating three significant problems:

• GDP compliance gaps with road carriers. Previous road freight providers could offer refrigerated trailers but lacked the documentation and quality management systems required for GDP-compliant pharmaceutical transport. Temperature logs were inconsistent, calibration certificates for monitoring equipment were often expired, and no carrier could provide the complete audit trail required during regulatory inspections by AEMPS (the Spanish medicines agency) or AIFA (Italy's equivalent).
• Prohibitive air freight costs. To guarantee compliance and speed, the distributor had defaulted to air freight for approximately 60% of Italian shipments. At an average cost of €8.50 per kilogram, air transport consumed a disproportionate share of the logistics budget — particularly for lower-value diagnostic reagents where freight costs represented up to 18% of product value.
• Temperature excursion risk during handling. The multimodal nature of air freight — involving ground transport to the airport, tarmac handling, flight, and final-mile delivery — introduced multiple temperature-vulnerable touchpoints. Over the previous 18 months, the distributor had recorded 7 temperature excursion events, resulting in €45,000 worth of rejected product and two customer complaints escalated to their quality department.

The Solution

Transroad deployed a dedicated GDP-compliant cold chain road freight service for the Valencia–Milan corridor:

• GDP-certified transport operations. Transroad holds GDP certification for pharmaceutical logistics, with all vehicles, drivers, and processes audited annually by an accredited body. The service operates under documented Standard Operating Procedures (SOPs) covering loading validation, in-transit monitoring, contingency protocols for equipment failure, and delivery verification.
• Continuous real-time temperature monitoring. Each shipment is equipped with calibrated dual-sensor temperature loggers that transmit data every 5 minutes via cellular network. The distributor's quality team has real-time dashboard access to temperature readings throughout transit, with automated alerts triggered if readings approach the 2°C or 8°C boundaries. Complete temperature records with full chain-of-custody documentation are delivered within 24 hours of each shipment's completion.
• Direct loading with minimised handling. Unlike air freight's multiple transfer points, Transroad's road service uses a single refrigerated vehicle from the Valencia warehouse to the Milan distribution centre. Product is loaded under supervision at origin and remains in the same controlled environment until unloading at destination, eliminating the handling gaps that previously caused excursions.
• 3-day guaranteed transit from Valencia to Milan, with twice-weekly departures on Monday and Thursday. Shipments are consolidated with other GDP-compliant pharmaceutical freight to optimise trailer utilisation while maintaining full segregation between different clients' products.

The Results

After 12 months of operation, the distributor documented substantial improvements across compliance, cost, and reliability metrics:

• Zero temperature excursions across 96 shipments, verified by continuous monitoring data — compared to 7 excursions in the prior 18 months using mixed air and road carriers.
• 30% cost reduction versus air freight, with average per-kilogram rates of €5.90 on the road service compared to €8.50 by air. Annual savings exceeded €62,000 on Italian shipments alone.
• Full GDP audit trail for every shipment, including calibration certificates, temperature logs, CMR documentation, and signed proof-of-delivery — all accessible through Transroad's compliance portal. The distributor passed their most recent AEMPS inspection with zero observations related to transport.
• 3-day reliable transit time, averaging 2.9 working days across all shipments, with a 100% on-time delivery rate against the contracted schedule.

Looking Ahead

Encouraged by the results, the distributor is extending Transroad's GDP cold chain service to cover their Spain–Germany pharmaceutical corridor, where similar compliance challenges exist with current carriers.

If your company ships pharmaceutical products, biologics, or other GDP-regulated goods across European borders (see our temperature-controlled freight guide), Transroad's certified cold chain service can help you reduce costs while maintaining full regulatory compliance. Request a custom quote from our pharmaceutical logistics team, or use our freight calculator to explore transit times and pricing on your specific corridor.