Assuring Product Quality for Temperature-Sensitive Cargo
The integrity of the cold chain is vital for pharmaceuticals, biologics, vaccines, high-value foods, and perishables. Even brief temperature excursions can cause spoilage, efficacy loss, and regulatory non-compliance under the FDA Food Safety Modernization Act (FSMA). Validating temperature control from production through distribution is essential.
BQCIS delivers end-to-end cold-chain validation—covering storage, insulated packaging, and refrigerated transport units. Through thermal mapping and qualification studies, we confirm that environments remain within required ranges (e.g. 2–8 °C or −20 °C) under dynamic stress conditions.
We also perform independent data-logger audits and real-time IoT monitoring during transit, ensuring continuous compliance with GFSI, WHO GDP, and FSMA standards. Our assurance protects both cargo quality and regulatory confidence across the logistics chain.
Key Cold-Chain Validation Activities
Key Benefits of Cold-Chain Assurance
Regulatory Compliance
Validates conformance to FSMA, WHO GDP, and GxP standards for temperature-controlled storage and transport systems.
Product Integrity
Prevents temperature excursions that degrade pharmaceuticals, foods, or biological materials—preserving quality and efficacy.
Operational Transparency
Provides verifiable digital audit trails for clients, insurers, and regulators via continuous monitoring and secure reporting.
Risk Reduction
Mitigates financial losses and recalls through proactive validation and real-time performance monitoring of cold-chain assets.
Success Story
Thermal Mapping Validates Pharmaceutical Cold-Storage Warehouse
A pharmaceutical distributor commissioning a 2–8 °C warehouse required independent validation to meet Good Distribution Practice (GDP) standards before vaccine storage approval.
BQCIS deployed 50+ calibrated loggers under multiple load and door-cycle scenarios. Data analysis identified thermal gradients and non-uniform airflow affecting temperature recovery.
Corrective HVAC adjustments and air-curtain installation eliminated hot zones. The final BQCIS qualification report achieved regulatory sign-off and operational readiness certification.