Transportation of medicinal products – some things to consider

The global supply chain is regarded as a storage area by regulators and the regulations have changed to reflect this with the EU GDP Guidelines that came into force in 2013.

Chapter 9 of the EU GDP Guidelines is dedicated to the subject.

It is the responsibility of the supplying wholesale distributor to ensure that,“the required storage conditions should be maintained during transportation within the defined limits as described by the manufacturer or on the outer packaging”… (of the product).

The transportation arrangements from one location to another should be regarded as an extension of the storage activities and distributors are expected to treat each journey as unique, with the length and complexity, as well as any seasonal variations, being considered when choosing the packing method and mode of distribution.

Forklift loader stacker truck
Forklift loader stacker truck. Copyright: kadmy

There are a high number of temperature sensitive products, remembering that ambient products are also temperature sensitive.




There are many other factors to consider, including:

  • the use of third party couriers/contracts/audit and review (see chapter 7)
  • mixed consignments/risk of contamination
  • the use of hubs/cross docking/transit storage
  • temperature mapping of the vehicle/temperature monitoring/calibrated devices
  • air circulation
  • journey time/length/contingency planning/weather/multi drop deliveries
  • security
  • cleanliness
  • driver training
  • appropriate use of qualified packaging and location of cool packs including adherence to seasonal review and reconfigurations
Modes of transport
Modes of transport. Copyright: TopVectors

Vehicles and equipment used to transport and handle products should be suitable and be equipped to prevent exposure to conditions that could impact on product quality.

Medicinal products should be transported in containers that will offer protection against, for example, adverse weather conditions and contamination and of course, maintain the required storage conditions for the entire length of the journey.

Containers should also display labels stating the required storage and handling conditions as well as the contents of the consignment.

If a deviation such as a temperature excursion or damage has occurred during transportation, this should be reported to both the distributor and the recipient.

The process of transportation should be supported by written procedures, form part of the self-audit programme and be subject to risk assessment and CAPA.

There is now more awareness that poor storage and transportation can impact on product quality and patient safety.  Poor transportation can result in:

  • recall
  • loss of confidence/reputation
  • regulatory action

Wholesale dealers should have:

  • a quality management system.
  • a continual quality improvement process.
  • a refrigerated products distribution strategy.
  • an ambient products distribution strategy.
  • a risk assessment programme.
  • a protocol in the event of theft /security breaches

We still have spaces available to hear from the GDP team at our January Symposium. Book now!

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Check out our guidance on good practice for information on the inspection process and staying compliant.

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  1. Comment by Gary Wang posted on

    What do you mean by Ambient Products?

  2. Comment by Paul R posted on

    Do these guidelines apply to IMP? If not, what equivalent GDP guidelines are there for IMP?

    • Replies to Paul R>

      Comment by Mark Birse posted on


      Whilst GDP isn't mentioned in the existing CT Directives, or the coming CT Regulation, the GDP guidelines offer a framework that can serve companies well in adopting suitable practices for distribution of clinical materials and sourcing of comparators.



  3. Comment by http://https// posted on

    That was interesting

  4. Comment by rpdmexpert posted on

    what a fantastic post! this so chock full of Transportation of medicinal products informations.I can't wait to dig deep and start utilizing the resources you have given me. your exuberance is refreshing.

  5. Comment by Sendhamarai Engineering posted on

    Welcome and useful tips.Thanks for sharing information.

  6. Comment by Rob P posted on

    If a product meets the folloowing stability there is no requirement to have storage conditions on the packaging.

    25°C/60%RH (long term)
    40°C/75%RH (accelerated)
    30°C/65%RH (long term)
    40°C/75%RH (accelerated)

    When are excursions expected to be reviewed in this case?

    • Replies to Rob P>

      Comment by Sara Berry posted on

      Dear Rob,
      All medicinal products should be stored in accordance with the label conditions and the details registered in the Marketing Authorisation. Any excursions outside the normal storage conditions should be subject to a documented investigation, and the causes of the excursion removed.
      Kind regards

      • Replies to Sara Berry>

        Comment by Rob P posted on

        So if there are no specific storage conditions on the label, as per CPMP/QWP/609/96/Rev 2, how is this defined, can we ship at any temperature?

        • Replies to Rob P>

          Comment by Sara Berry posted on

          Please refer to the following link which has been recently published:

          Marketing authorsiation holders have to provide stability data for storage conditions at 25°C / 60% relative humidity (RH), or 30°C / 65% RH (long term) and 40°C / 75% RH (accelerated), in order to justify not including a statement in the medicinal product labeling

          No labeling statement means that controls should be in place to maintain conditions relevant to the climate zones. Consequently, the temperature should be monitored during storage and transport and appropriate limits set for temperature monitoring to ensure the product stability is not affected.