Cold Chain

The temperature-controlled supply chain that keeps a product within its required temperature range from manufacture to use.

Cold-chain integrity is demonstrated through qualified packaging, lane qualification, continuous monitoring and a documented response to any excursion.

For many biologics the cold chain is the single biggest risk to product quality in transit.

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Cold Chain Lane Qualification

Related terms

Temperature Excursion Time At Elevated Temperature (TAET) and Stability Budget

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Eight guided flows: compliance review, DPS screening, Part 11 e-signature, custody chain, breach prediction, GDPR erasure and the validation report. Then a 90-day pilot on your own programme, fully creditable.

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