Legal basis
The rules for transporting medicines are set out in the European Commission Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use (2013/C 343/01). Chapter 9 covers transportation. EU member states apply the same requirements nationally – in Poland, for example, through a Ministry of Health regulation of 13 March 2015. Responsibility for conditions during transport lies with the supplying wholesale distributor, even when the transport is subcontracted.
What exactly GDP requires
The key requirements of Chapter 9:
- Labelled conditions – the storage conditions described by the manufacturer or on the outer packaging are maintained during transport.
- Route risk assessment – determines on which routes temperature control is needed.
- Calibration – temperature monitoring equipment in vehicles and containers is maintained and calibrated at regular intervals, at least once a year.
- Deviations – any deviation, such as a temperature excursion, is reported promptly to the distributor and the recipient; a procedure for investigating excursions is required.
- Transshipment – where a route includes unloading, reloading or transit storage, temperature is monitored there too.
- Mapping – temperature mapping of temperature-controlled vehicles is carried out under representative conditions, taking seasonal variation into account.
- Records – documentation proving correct temperatures during transport is made available to the recipient on request.
- Cool packs – must not come into direct contact with the product.
How to build GDP-compliant monitoring
- Map the cargo space. Find the warmest and coldest spots in the reefer or trailer – in summer and in winter. Place the sensors there.
- Measure continuously, with alarms. A logger read only after delivery shows the problem too late. An online system raises an alarm when the temperature leaves the range, e.g. 2–8 °C, so the driver or dispatcher can act during the trip.
- Link temperature with door opening and GPS position. Every stop with open doors risks an excursion. When the chart shows the door opening, place and time, the root cause is easier to investigate.
- Keep calibration up to date. Plan sensor calibration at least once a year and keep the certificates. Ask your supplier how calibration is done for the specific model.
- Archive data for the customer and the inspector. A temperature report for every delivery should be available without retyping anything.
- Write the procedures. Who receives the alarm, what the driver does, when goods go into quarantine and how the customer is informed.
STARCONT devices for the cold chain
- TSTH1-B – Bluetooth temperature (±0.2 °C at 0–60 °C) and humidity (±2% RH) sensor.
- T-one – sensor with an external probe (-40…+125 °C); only the probe goes into the cold zone, the housing stays outside.
- TSDT1-B and T-Sense – door opening and temperature in one sensor.
- Kylos Label – single-use LTE-M / NB-IoT tracking label for parcels and pallets.
- PLUSFLEET – fleet platform with temperature control.
Bluetooth sensors send readings to the tracker in the vehicle, which forwards them to an online platform with alarms and history. The accuracies quoted come from the manufacturer's datasheets. Whether a given set-up meets your quality system is confirmed by your own validation. You can try it with a starter kit.