FDA cold chain compliance – Clinical Research Made Simple

Inspection Readiness Playbook – Cold Chain Monitoring for Biological Samples

September 25, 2025

Inspection Readiness Playbook – Cold Chain Monitoring for Biological Samples Inspection Readiness Playbook – Cold Chain Monitoring for Biological Samples Introduction: Cold Chain Monitoring as a Regulatory Priority Maintaining the cold chain—the uninterrupted temperature-controlled transport and storage of biological samples—is critical in clinical trials involving pharmacokinetics, biomarkers, vaccines, and advanced therapies. Any deviation from defined…

Laboratory and Sample Management, Sample Labeling and Transport

Monitoring and Recording Temperature Excursions in Clinical Trials

June 28, 2025

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Monitoring and Recording Temperature Excursions in Clinical Trials How to Monitor and Record Temperature Excursions in Clinical Trials In clinical trials involving temperature-sensitive investigational products (IPs), monitoring and documenting temperature excursions is essential for ensuring product integrity and regulatory compliance. A temperature excursion refers to any event where an IP is exposed to conditions outside…

Clinical Trial Supply and Logistics, Cold Chain Logistics