Trusted Resource for Clinical Trials, Protocols & Progress
Interruptions in supply can delay patient dosing, cause data loss, and compromise trial outcomes. Early risk identification allows teams to proactively implement controls, build resilience, and ensure readiness for audits by regulators like EMA or CDSCO.
Click to read the full article.
Scenario: A biologic IP shipped from Germany to India was delayed in customs for 72 hours. The shipment exceeded the 2–8°C range for 14 hours.
Click to read the full article.
Temperature excursions can jeopardize the safety, efficacy, and stability of IPs. Human errors—such as mishandling shipments, incorrect logger usage, or delayed deviation reporting—are among the most common root causes. Proper training reduces these risks and helps meet USFDA, EMA, and CDSCO requirements.
Click to read the full article.
A cold chain deviation is any unplanned event where a temperature-sensitive IP is exposed to conditions outside its predefined storage range (e.g., 2–8°C or -20°C). Deviations may occur in transit, at clinical sites, depots, or storage facilities.
Click to read the full article.
Temperature excursions during transit can result in product degradation, protocol non-compliance, and costly delays. Regulatory bodies like the USFDA and EMA require proof that IPs remained within acceptable conditions during shipment. Real-time tracking offers immediate insights into shipment conditions, location, and alerts in case of deviation.
Click to read the full article.
