GMP in pharmaceutical transport – what requirements must a transport company meet?

Transport companies serving the pharmaceutical industry operate in one of the most demanding sectors of logistics. Medicines are not ordinary goods – any loss of efficacy during transport can directly endanger a patient’s health or life. Good Distribution Practice imposes specific obligations on transport companies, the fulfilment of which is a prerequisite for the lawful provision of services to pharmaceutical wholesalers and hospitals.

Legal status of a transport company within the DPD system

A transport company carrying out the transport of medicinal products on behalf of a pharmaceutical wholesaler is not required to obtain a GIF licence for the wholesale distribution of medicines itself – this obligation rests with the client. However, this does not exempt it from the obligation to meet DPD’s transport requirements. Carriers providing services to wholesalers do not need to register their vehicles themselves, as this obligation rests with the entity holding the authorisation; however, they must provide the client with full technical documentation for the vehicles and certificates confirming compliance with GDP requirements.

In practice, this means that a pharmaceutical wholesaler is obliged to qualify each transport subcontractor and verify that they meet DPD’s requirements. A transport company without a documented quality system and certified vehicles will not pass the qualification process and will not receive the contract. DPD certification for transport companies has become a prerequisite for entering the market in the pharmaceutical sector – without it, providing transport services to this sector is, in practice, impossible.

It is worth noting a significant procedural change: from 1 February 2026, a new vehicle registration procedure will come into force, under which operators must create a profile in a dedicated application separately for each warehouse they operate. Transport companies must be aware of these requirements and ensure that documentation is up to date for each client.

Vehicle Qualification and Temperature Control

Monitoring temperature conditions during transport is DPD’s most important technical requirement for transport companies. A key requirement when transporting pharmaceutical products is to ensure strictly defined conditions, particularly with regard to monitoring and maintaining a controlled temperature inside the cargo area.

Every vehicle used to transport medicinal products must undergo qualification – documented confirmation that it is capable of maintaining the required temperature conditions. Qualification involves temperature mapping of the cargo area, testing the refrigeration system’s performance under extreme weather conditions, and technical documentation of the refrigeration unit and temperature recording system.

The most common temperature ranges for transport are 2–8°C and 15–25°C; the standard also provides for other ranges, including sub-zero temperatures used, for example, for the transport of vaccines. For each temperature range, qualification must be carried out separately and repeated after any significant modification to the vehicle or refrigeration system.

Temperature recorders used in vehicles must comply with the requirements of standard PN-EN 12830 and be subject to periodic testing in accordance with standard PN-EN 13486:2024-06. Data from the recorders must be archived and made available to the wholesaler commissioning the transport – it serves as proof that the required conditions have been maintained for each delivery carried out.

System and organisational requirements

In addition to vehicle certification, the transport company must have a documented quality management system covering several key areas.

• Loading and unloading procedures – specifying how to minimise the time products are exposed to external conditions, the loading sequence, requirements for transport packaging, and procedures to follow in the event of damage to goods
• Emergency procedures – describing the procedure in the event of a refrigeration unit failure, a road accident, extreme weather conditions or a delivery delay – including rules for notifying the client and assessing the impact of temperature deviations on product quality
• Vehicle hygiene – procedures for cleaning and disinfecting the load compartment, preventing cross-contamination between different loads, and prohibiting the transport of medicinal products alongside goods that may pose a risk to their quality
• Driver training – staff involved in pharmaceutical transport must be trained in DPD’s requirements, temperature control procedures and emergency protocols. Training must be documented and regularly refreshed
• Transport documentation – every delivery must be accompanied by complete documentation enabling the identification of the products, transport conditions and the persons responsible for carrying out the order.

A well-designed DPD system helps to meet the requirements set by the pharmaceutical industry and prepares the organisation for qualification by business partners and inspections by the GIF.