The GDP transport guide for cold chain compliance provides a means to overcome product insecurity during transportation. The distribution and storage procedures require temperature monitoring to ensure product efficacy and safety.
Whenever temperature-sensitive pharmaceutical products are exposed to temperatures above or below the specified range, they experience temperature excursions. These excursions can affect their potency or jeopardize the patient’s health.
Mean kinetic temperature MKT is a weighted average temperature which summarizes the thermal challenge a drug substance or product would experience over a range of various temperatures for a defined period of time. It is used during a stability study.
A stability budget is the amount of time a product can spend out of its specified storage conditions without risk to its quality, safety, or efficacy. Find out how to perform a stability test and prepare a stability budget for your cold chain.
Digital dashboards for cold chain temperature monitoring management can be networked, remote from a multi-user cloud server, helping deliveries arrive faster and more precise, decreasing accidental loss of cargo.
Automated control systems are in each part of the cold chain, from manufacturing, to storage and distribution. Smart location, logistics, condition package management sensors and software govern every step of the process.
Real-time cold chain monitoring is the delivery of continuously updated temperature data at zero or low latency. Getting data in real-time provides the opportunity to respond to problems right away and to reveal and predict trends.
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