How pharma cold chains are rethinking trust and accountability

A pharmaceutical shipment rarely announces that something has gone wrong.

A box moves from warehouse to vehicle, from airport to distribution centre and finally to a customer or healthcare facility. The packaging appears intact, the paperwork looks complete, and delivery timelines are met. Yet somewhere along that journey, even a slight shift in temperature can quietly compromise product integrity. In a sector where temperature-sensitive medicines depend on precise handling, what matters is not simply whether a shipment arrived, but whether it remained safe throughout its journey.

That quiet vulnerability is forcing pharma companies to rethink a difficult question. When a cold chain deviation occurs, who decides what really happened?

Increasingly, the answer appears to lie not in assumptions, internal explanations or conflicting partner accounts, but in evidence.

Across pharmaceutical cold chains, companies are placing growing emphasis on validated packaging, temperature monitoring, data logging and structured investigations to determine accountability when shipments deviate from required conditions. The focus is moving beyond blaming one party and towards establishing a verifiable chain of events.

The discussion formed part of the Pharma Supply Chain Summit held at the Intralogistics Warehousing Expo, a three-day conference and networking platform focused on logistics, warehousing, automation and supply chain operations. The session on cold chain execution brought together Hanoz Tarapore, Country Supply Chain Head for ASEAN, KR and ANZ at QuidelOrtho; Manish Bhutani, India Lead for Life Sciences and Healthcare at DHL Express India; Vineet Kumar, Senior Manager SCM Warehouse & Logistics at Elanco; Ratnakar Satapathy, Team Leader at Ferring Pharmaceuticals; Manoj Nolkha, India Deliver Head Pharma at Johnson & Johnson; and Manfred Merthan, CEO at Efaflex, with the discussion moderated by Tejas Mehta, AVP and Head of Logistics and MSS at Reliance Life Sciences

Trust is no longer enough, and proof matters
Cold chain logistics have always depended on coordination between multiple partners. Warehousing providers, packaging vendors, logistics operators, transport companies and receiving facilities all touch a shipment at different points. When a temperature deviation takes place, however, every participant may hold a different version of events.

That complexity is increasingly pushing companies towards what many now view as a more objective standard, recorded temperature evidence.

According to a report by Rinac, pharmaceutical cold storage systems are evolving beyond refrigeration alone towards continuous monitoring, data visibility and compliance assurance, reflecting growing expectations around traceability and proof of temperature integrity. Rinac, is an Indian company that designs and provides cold chain, cleanroom, refrigeration and temperature-controlled infrastructure solutions for sectors including pharmaceuticals, healthcare and food logistics.

That practical reality was reflected in how executives described deviation management.

“There is no he said, she said in that,” said Hanoz Tarapore, Country Supply Chain Head for ASEAN, KR and ANZ at QuidelOrtho, explaining how disagreements between supply chain partners are handled during temperature excursions.

Tarapore argued that when disputes emerge, the temperature data logger effectively becomes the “single source of truth”.

Different parts of the chain may blame one another, he suggested, but recorded data narrows the room for interpretation. In many cases, even insurers require evidence from data loggers before claims can move forward.

The implication is significant. Accountability in pharma logistics is becoming less dependent on narrative and more dependent on measurable proof.

The cold chain begins long before transport
Evidence alone, however, does not tell the full story.

Before a shipment even moves, another decision has already been made. How long should packaging realistically protect a product, and under what conditions?

Temperature-sensitive medicines are not merely placed into refrigerated environments and forgotten. Packaging is designed and validated to withstand specific timeframes and conditions, often with tightly controlled expectations around temperature maintenance.

Vineet Kumar, Senior Manager SCM Warehouse & Logistics at Elanco, pointed to the importance of linking validated packaging with continuous monitoring.

If packaging is designed to sustain a shipment for 72 or 96 hours, companies must still track temperature from origin to customer through monitoring systems and data loggers, he explained. Temperature graphs then provide evidence of whether shipments stayed within acceptable thresholds, such as the common 2°C to 8°C range required for many products.

In practical terms, this changes how integrity is judged.

A shipment is no longer considered successful simply because it reached its destination. It must prove that environmental conditions remained compliant throughout transit.

If temperatures remain within defined limits, investigation may not be necessary. When excursions occur, however, the process shifts immediately towards scrutiny.

That emphasis aligns with observations from GND Solutions, a cold chain provider, which highlights the growing need for uninterrupted monitoring and reliable environmental control across supply chains handling temperature-sensitive products.

Why assigning blame is often the wrong starting point
When something goes wrong in the cold chain, instinct often pushes organisations towards one question: who failed?

Several industry leaders increasingly argue that this approach oversimplifies reality.

A deviation may appear operationally straightforward, yet the causes are often layered.

Was the packaging done correctly? Did the packaging solution perform as expected? Did transport conditions remain compliant? Was receiving handled properly? Was data captured accurately?

Tejas Mehta, AVP and Head of Logistics and MSS at Reliance Life Sciences, described deviations as problems that require openness rather than finger-pointing.

His emphasis was not on identifying a single guilty party, but on systematically evaluating every stage of the chain.

Cold chain failures, in that sense, become ecosystem failures.

Warehousing, packaging, transportation, product handling and documentation all intersect. Weakness at one point can trigger consequences elsewhere.

For Mehta, investigation must remain transparent and thorough. Mistakes, he argued, should not immediately become grounds for accusation but opportunities for improvement.

The philosophy reflects a broader shift taking place in pharma logistics. Operational maturity increasingly depends on learning from failure rather than merely containing it.

The reputational stakes are also growing.

Financial losses may be recoverable, Mehta suggested, but damaged trust is harder to restore.

In pharma, that distinction matters profoundly. A temperature-sensitive medicine that loses integrity affects more than inventory value. It raises questions around compliance, reliability and patient safety.

From deviation to discipline
If data loggers establish facts and investigations identify causes, the next challenge becomes prevention.

This is where root-cause analysis is increasingly taking centre stage.

According to a report by Pharma Regulatory, structured investigation plays a central role in determining why temperature excursions occur, requiring documentation, corrective actions and preventive processes to avoid recurrence.

Rather than treating a deviation as a standalone operational incident, the approach reframes it as part of a larger quality system.

Manish Bhutani, India Lead for Life Sciences and Healthcare at DHL Express India, described the process as one of disciplined repetition.

First comes investigation and root-cause analysis. Then, corrective action plans must be implemented. Finally, organisations must review processes to ensure the same failures are not repeated, he explained.

This may sound procedural, but it reflects something deeper about how pharma cold chains are evolving.

The industry is quietly moving from reactive response to operational resilience.

A deviation no longer ends with identifying what went wrong. Increasingly, the expectation is to redesign systems so the same weakness does not appear again.

The future of the cold chain may depend on evidence, not assumptions
Cold chains are often discussed in terms of infrastructure, refrigerated trucks, cold rooms, storage systems and investment.

Yet the more difficult challenge may not be building the cold chain, but proving that it worked exactly as intended.

As pharmaceutical supply chains become more distributed and partner-driven, accountability is becoming harder to establish through conversation alone. Recorded temperature evidence, validated packaging, end-to-end monitoring and disciplined investigations are emerging as the mechanisms through which trust is maintained.

The lesson is deceptively simple.

When temperature-sensitive medicines move across warehouses, airports and distribution networks, success is not determined by speed or delivery alone. It is determined by whether every participant can demonstrate, clearly and honestly, that the product remained protected from beginning to end.