Quality Assurance in Animal Health Supply Chains: How to Mitigate Risks
In the animal health industry, innovation doesn’t end when a new therapy leaves the lab. From the moment a product is ready to move, its quality depends on one thing above all else: a controlled, reliable supply chain. In this context, quality assurance (QA) goes beyond a regulatory requirement and quickly becomes a critical safeguard that ensures every shipment maintains its efficacy and compliance throughout the complexities of transport.
Even with as far as the market has come, too many animal health companies underestimate the risks hidden within their logistics networks. A small deviation in temperature. A shipment delay. A lack of visibility between handoffs. Any one event can quietly compromise product quality and disrupt operations, and any unexpected deviation can threaten the trust of veterinarians and producers who rely on timely, effective therapeutics. At Cryoport Systems, we believe that QA must be built into every layer of the supply chain.
Validated Systems Create a Foundation of Trust
When the product you’re transporting is an advanced therapeutic, “good enough” simply isn’t good enough. The equipment used to ship temperature-sensitive materials must undergo rigorous validation to confirm that it performs as intended under real-world conditions. That means detailed qualification protocols that meet or exceed industry standards.
Cryoport Systems employs validated, custom-engineered shipping systems designed specifically for biologics and other sensitive materials for the life sciences. Each system undergoes qualification and requalification before every use, ensuring consistency from the first shipment to the millionth. This validation process isn’t a single step, but is an ongoing commitment to reliability that eliminates one of the most common sources of variability in sensitive supply chains.
Continuous Monitoring and Full Transparency
You can’t mitigate what you can’t see. True quality assurance requires complete visibility into the conditions and location of every shipment throughout its journey. That’s why modern QA frameworks rely on continuous monitoring systems that provide insight into critical parameters like temperature, orientation, and handling.
Cryoport Systems’ Smartpak™ condition monitoring system delivers that level of transparency. It tracks critical parameters throughout transport and feeds data directly into our Cryoportal® logistics management system, where our team monitors every shipment 24/7/365 and responds to near real-time alerts. This oversight allows for immediate intervention if an anomaly occurs, preventing small deviations from becoming costly product losses.
Transparency also extends beyond active monitoring. With our Chain of Compliance®, we maintain a fully traceable record of every shipment’s custody, condition, and equipment performance history. This end-to-end documentation supports audit readiness and gives animal health organizations the confidence that their logistics meet the same standards applied in human therapeutics.
Proactive Risk Mitigation through Quality Frameworks
The most effective way to handle risk is to prevent it. Robust quality frameworks transform logistics from a reactive process into a proactive one, identifying potential vulnerabilities and addressing them before they become problems.
For example, by analyzing data from more than a million successful shipments worldwide, Cryoport Systems helps clients identify patterns that could signal risks, like specific routes that are prone to delays, environmental conditions that challenge product stability, or carrier handoffs that increase variability. These insights, alongside specialized consulting and advisory services for shipping risk assessments and shipping lane qualifications that support your regulatory filings, allow for corrective action and continuous improvement across the entire supply chain.
Elevating Standards in a Changing Regulatory Landscape
Animal health regulations are evolving rapidly, aligning ever more closely with human biopharmaceutical standards. For logistics providers, this means adopting frameworks and standards such as ISO 21973, which governs the safe transport of cells for therapeutic use. Cryoport Systems adheres to these same stringent global standards for animal health shipments, ensuring compliance that anticipates (rather than reacts to) future regulatory expectations.
By applying the most stringent human health standards to animal health logistics, we provide an additional layer of protection as compliance isn’t just about meeting requirements, it’s about a proactive commitment to quality and accountability at every step.
Building Resilience Through Quality
Every product in the animal health industry represents a vital link in the chain of care, be it from the lab to the farm or the manufacturer to the field. A strong QA framework ensures that this chain remains unbroken, no matter how complex the logistics become.
At Cryoport Systems, QA goes beyond being a department within the company and instead functions as the foundation of how we operate. From validated shipping systems and continuous monitoring to our global Chain of Compliance and ISO-aligned standards, every detail is designed to mitigate risk and Enable the Outcome™.
