Pharmaceutical transport: a practical guide

What transport has to achieve

The EU guidelines on good distribution practice put it in two sentences. The distributor supplying the product is responsible for protecting it against breakage, adulteration, and theft, and for keeping temperature conditions within acceptable limits during transport. And whatever the mode, it should be possible to demonstrate that the product has not been exposed to conditions that may compromise its quality.

That second sentence is the one that shapes everything else. Holding the temperature is not enough; a distributor has to be able to prove it held, shipment by shipment, to a customer or an inspector who asks. The guidelines also ask for a risk-based approach to planning transport, which is why lanes, packaging, and monitoring are chosen per route rather than once for everything.

Temperature classes for medicines in transit

A medicine's storage condition comes from its manufacturer's stability studies and is printed on the label. Transport inherits it. The common classes, with the ranges the World Health Organization gives for them:

Controlled room temperature

15 to 25 °C in WHO's definition. USP currently defines it more narrowly, as 20 to 25 °C with excursions between 15 and 30 °C permitted, and a 2026 USP proposal would lower the floor to 15 °C. EU labels do not use the term; they say "Do not store above 25 °C" or "30 °C".

Refrigerated

2 to 8 °C, written by WHO as 5 ± 3 °C.

Frozen

−25 to −15 °C, written by WHO as −20 ± 5 °C.

Deep frozen

−80 to −60 °C, written by WHO as −70 ± 10 °C.

Cryogenic

far colder, in dry shippers that hold product in the vapor of liquid nitrogen, for cell and gene therapies. There is no regulatory range for it; WHO's guidance asks for special care with dry ice and liquid nitrogen, because of the safety risks and their possible effect on product quality.

The transport rules for dry ice and for liquid nitrogen dry shippers are in our guide to shipping with dry ice.

WHO also advises against "store under ambient conditions" on a label, because ambient means different things in different climates.

A label can set humidity as well as temperature. For "Store in a dry place" and "Protect from moisture", WHO's recommended limit is no more than 60% relative humidity.

Pharmaceutical transport regulations in the EU, UK, and US

Transport rules differ by market, but they ask for the same things: a known range, equipment able to hold it, evidence that it did, and a procedure for when it did not.

European Union

chapter 9 of the Guidelines on Good Distribution Practice of medicinal products for human use (2013/C 343/01). It covers transport (9.2), containers, packaging and labeling (9.3), and products that need special conditions (9.4). Among other things: delivery routes are risk-assessed to decide where temperature control is needed, monitoring equipment used in transport is calibrated at least once a year, and a temperature excursion is reported to the distributor and the recipient and investigated under a written procedure.

United Kingdom

Great Britain still applies the EU guidelines as they stood at the end of 2020, under the Human Medicines Regulations 2012; Northern Ireland follows the EU text directly.

United States

there is no single federal regulation on good distribution practice. Manufacturers follow the current good manufacturing practice (CGMP) rules on warehousing and distribution (21 CFR 211.142 and 211.150), state licensing of wholesale distributors follows the minimum standards in 21 CFR 205.50, and the USP <1079> chapters describe good storage and distribution practice. The Drug Supply Chain Security Act governs tracing, not temperature.

Worldwide

WHO's Good storage and distribution practices for medical products (TRS 1025, Annex 7, 2020) and its technical supplements on transport (2015): road and air operations, qualification of shipping containers, transport route profiling, and monitoring systems.

Air

IATA's Temperature Control Regulations set how airlines and forwarders handle healthcare shipments, and IATA's CEIV Pharma program certifies handling capability along the air cargo chain.

Our guide to good distribution practice covers the rest of the EU guidelines, chapter by chapter.

Who is responsible for what

A shipment passes through several companies' hands, and the rules allocate the responsibility rather than leave it with whoever holds the box.

The manufacturer

sets the storage condition from stability data. It is the reference every later decision is made against.

The supplying wholesale distributor

is responsible for protecting the product in transit under EU GDP, including when it contracts the transport out.

The Responsible Person

named on the distributor's authorization, decides the final disposition of returned, rejected, or recalled product. The role can delegate duties but not responsibilities.

The shipper

is, in WHO's words, generally responsible for temperature compliance in transport, and sets the requirements in its agreements with carriers.

Carriers, forwarders, and logistics providers

work under a written contract that defines each party's duties. Under EU GDP the contract giver audits them before work starts, and they may not subcontract without its approval.

Where the risk sits: air, road, ocean, and the last mile

Each mode has its own weak points, and they cluster where control passes from one party to another.

Air

WHO's guidance on road and air transport names the airport apron as the place of greatest and most frequent exposure to temperature variation, and handovers as the moments product is most at risk of improper handling. The same guidance notes that temperature control in most aircraft holds is limited, and that it varies with where the shipment sits, the time at altitude, and the length of the flight.

Road

vehicles are qualified and temperature-mapped under representative conditions, with seasonal variation taken into account, and EU GDP asks for particular attention to monitoring wherever product is unloaded, reloaded, or held at a hub.

Ocean

is covered by WHO's monitoring guidance for active shipping systems but has no chapter of its own in the transport guidance. Long transit times put the weight on container power and on knowing, during the voyage, that the container is still holding its setpoint.

The last mile

IQVIA's 2023 analysis of cold chain medicines found that excursions occur more often in the last stage of the chain than earlier.

What happens when a shipment does leave its range is covered in our guide to temperature excursions.

Packaging: passive and active

Temperature-sensitive product travels in one of two kinds of system, and the choice follows the route, the duration, and the range.

Passive systems

are insulated shippers holding a finite amount of preconditioned coolant: gel packs, phase change materials, or dry ice. They need no power and run out of cooling at a predictable rate.

Active systems

are powered and thermostatically controlled: refrigerated trucks and temperature-controlled air and ocean containers.

EU GDP lists what the choice of container and packaging should rest on: the product's storage and transport requirements, the space it needs, the outside temperature extremes expected, the longest likely journey including storage at customs, and whether the packaging and containers are qualified. Where cool packs go into insulated boxes, they must not touch the product, and the staff who pack the boxes are trained on each season's configuration.

Either way, the packaging is qualified before it is used. WHO's guidance describes three stages: design qualification, operational qualification in a laboratory, and performance qualification in the field, on real routes. It makes one exception to the field stage: performance qualification is mandatory in all cases except where every shipment on every route is monitored. For parcel shipments, the ISTA 7E standard gives thermal test profiles based on measured parcel journeys.

Lanes: knowing the route before you ship

A lane is a transport route from a point of origin to a destination. Before product ships on one, WHO recommends profiling it: sending devices along the route to record the real ambient temperatures the packaging will meet, sampled every 10 to 30 minutes, across both the hot and the cold season. About 30 trips a year on a route is considered statistically valid. The profile then sets what the packaging has to withstand, and EU GDP's route risk assessment uses it to decide where temperature control is needed.

A profile ages as carriers, hubs, and seasons change, which is the case for keeping the risk score of a lane current with every shipment that runs on it. We make that argument in Why lane risk assessment is the cleanest first use case for AI in pharma.

Monitoring in transit

The guidance requires that temperature in transit be monitored, recorded, and demonstrable. It does not prescribe a technology, a recording interval, or real-time transmission. What it does set:

Calibration

EU GDP: monitoring equipment used in transport is calibrated at regular intervals, at least once a year. WHO: reusable devices are calibrated against a traceable reference once a year unless otherwise justified; single-use devices come with a manufacturer's calibration certificate and cannot be recalibrated.

Records

WHO expects downloaded data to be kept for at least three years in most cases, and accepts a secure web-based repository.

Purpose

a device is chosen for what its data will decide: accepting or rejecting a shipment on arrival, or trending a lane over time.

Our guide to cold chain monitoring devices compares indicators, devices read on arrival, and real-time devices, and what each can prove. When real-time monitoring is worth its cost, and when it is not, is the subject of why real-time temperature monitoring.

In air cargo, an active device with a battery travels under rules of its own. The IATA Dangerous Goods Regulations (67th edition, 2026) exempt tracking devices that are attached to or placed in packages and in use during the journey, provided each lithium-ion cell or battery is rated at no more than 20 Wh, or each lithium metal cell or battery contains no more than 1 g of lithium, and the device meets the other conditions of section 1.2.7.1(i), among them a standard on radio emissions so that it cannot interfere with the aircraft's systems. For a device that stays switched on in the hold, the US Federal Aviation Administration (FAA) advisory circular that IATA's guidance reproduces, AC 91.21-1D, sets the emission limits of RTCA DO-160, Section 21, Category H, in every mode of operation. A device that does not meet them needs at least two independent ways of sensing flight, each from a different source, that switch it or its cellular radio off when airborne. Low-power links such as Bluetooth may stay on. The airline approves each device model, under IATA Recommended Practice 1693, and an unapproved device can see the cargo held, delayed, or returned.

Whether a particular device may fly is a question for its maker's documentation; Controlant answers it for its own devices on the Controlant Support Center.

Receipt, quarantine, and release

Arrival is where the record is read. EU GDP asks the receiving site to check that the consignment is correct, from an approved supplier, and not visibly damaged, and to move temperature-sensitive product into proper storage first. WHO adds that the transport temperature data is reviewed on receipt, and that nothing goes into saleable stock until an authorized release is obtained.

If the record shows an excursion, the product is held in quarantine while it is assessed against its stability data, and the Responsible Person decides what happens to it. The faster the record is complete, the shorter that hold.

Where Controlant fits

Controlant monitors shipments in real time with reusable devices that report temperature and location while the shipment moves, so an excursion is seen when it starts rather than when the box is opened. Our MARS team watches shipments 24/7/365 against the limits a customer's quality team sets and acts on alarms by its work instructions, and Zero-Touch Release can release product automatically when it stayed within its stability budget, based on rules the customer's quality team sets.