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Pharma supply chain insights.

Showing guides. 9 posts.

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Guides

2026

Guide2 Nov 2026
Product release after transport: from manual review to release by exception
Before a shipment of medicines goes into stock, its transport record is reviewed and the product released. Key considerations: what the receiving site checks, why manual review is slow, and what has to be in place to release by exception, so that only the shipments that need a person reach one.
Guide2 Nov 2026
Data integrity for temperature records: 21 CFR Part 11 and Annex 11
21 CFR Part 11 and EU GMP Annex 11 set out when an electronic record can be trusted like paper. What they, and the data integrity guidance built on ALCOA+, ask of a shipment's temperature record: audit trails, electronic signatures, validation, access control, and retention.
Guide2 Nov 2026
Shipping with dry ice: the rules, the packout, and the record
Dry ice sublimes at about −78 °C (−109 °F) and is dangerous goods in the air. What the IATA and US rules ask of the package and the paperwork, how sublimation sets the length of a packout, what the temperature record has to show, and how liquid nitrogen dry shippers go colder.
Guide8 Oct 2026
Defining a temperature excursion
Any time a product is exposed to temperatures outside the range set for its storage or transport is a temperature excursion. It doesn't always mean the product is damaged, but the product is held until it has been assessed, so it's important to know what to do next, what the rules say, and why.
Guide8 Oct 2026
Mean kinetic temperature (MKT): how it is calculated and when it can be used
Mean kinetic temperature turns a varying temperature record into the one steady temperature that would have done the same damage. How it is calculated, a worked example, and what USP <1079.2> allows it to be used for.
Guide8 Oct 2026
Pharmaceutical transport: a practical guide
How medicines move from plant to patient within their labeled conditions: the temperature classes, the rules that apply in the EU, the UK, and the US, who is responsible for what, and where the risk sits on each leg.
Guide8 Oct 2026
Cold chain monitoring devices: indicators, data loggers, and real-time devices
Cold chain monitoring devices, the indicators and data loggers that travel with temperature-sensitive medicines, differ in two ways that matter: whether they keep a full history or only show that a limit was crossed, and whether that record can be read while the shipment moves or only after it arrives.
Guide8 Oct 2026
Time-temperature indicators: how they work and what they can show
What threshold labels, time-temperature integrators, freeze indicators, and vaccine vial monitors show, how an indicator is read on receipt, and what it cannot tell you about an excursion.
Guide8 Oct 2026
Good distribution practice (GDP): what it requires
What the EU good distribution practice guidelines require, chapter by chapter: who has to comply, what the Responsible Person does, what GDP says about temperature, how inspections and certificates work, and what applies in the UK and the US.

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Guides

2026

Product release after transport: from manual review to release by exception

Data integrity for temperature records: 21 CFR Part 11 and Annex 11

Shipping with dry ice: the rules, the packout, and the record

Defining a temperature excursion

Mean kinetic temperature (MKT): how it is calculated and when it can be used

Pharmaceutical transport: a practical guide

Cold chain monitoring devices: indicators, data loggers, and real-time devices

Time-temperature indicators: how they work and what they can show

Good distribution practice (GDP): what it requires

See the platform working on shipments like yours