Cold-Chain Shipping Validation and Validation Consulting
Shipping validation for UroGen Pharma's temperature-controlled distribution, from protocols and thermal profiling to GDP procedures, plus ongoing facility, utility and equipment validation consulting.
Shipping validationThermal profilingTransit risk assessmentGDP SOPsC&Q consulting
The Brief
UroGen Pharma develops and markets sustained-release hydrogel and oncology treatments. Shipping its formulations across borders and to clinical sites requires Good Distribution Practice and FDA-compliant temperature control that holds up under extreme transit conditions without affecting product quality.
What We Did
- Shipping validation: wrote the cold-chain protocols (VMP, VP, IQ/OQ/PQ) for insulated packaging, active and passive containers, temperature loggers and distribution lanes.
- Thermal profiling and transit testing: coordinated transit simulations, summer and winter ambient profiles and route risk analysis for the +2 to +8 °C and controlled room temperature ranges.
- Validation consulting: ongoing protocols and advice across facility, utility and equipment validation, supporting data integrity and cGMP readiness.
- GDP procedures: SOPs for cold-chain deviations, temperature excursions, receipt and inspection, and transport qualification reports.
Result
A documented, inspection-ready cold chain from the manufacturing dock to the clinical site.
Planning a Facility, a Line or a Validation?
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