Certification of medicine transport vehicles – GDP requirements in practice

COCH article in the quarterly “Świat Przemysłu Farmaceutycznego” 1/2025

COCH article in the quarterly “Świat Przemysłu Farmaceutycznego” 1/2025

Requirements related to the transport of medicines are becoming increasingly stringent. Good Distribution Practice (GDP) is no longer merely a formal requirement – it is an essential element of quality management throughout the pharmaceutical product supply chain. In an article published in the first 2025 issue of the quarterly “Świat Przemysłu Farmaceutycznego”, experts from the Central Refrigeration Centre “COCH” in Kraków – MSc Eng. Miłosz Gratkowski and MSc Eng. Bogdan Szczepański – present a comprehensive overview of the certification of transport equipment in accordance with GDP requirements.

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Why must medicine transport meet special requirements?

Pharmaceutical products are substances highly sensitive to environmental conditions, especially temperature. Ensuring a controlled atmosphere during transport is critical to maintaining their efficacy and safety. That is why medicine logistics must be based on rigorous standards and conformity assessment systems, among which GDP – Good Distribution Practice – occupies a central place.

What do the GDP guidelines cover?

The GDP guidelines of 5 November 2013 cover a wide range of topics, including:

• quality management system (including risk analysis and relationships with subcontractors),
• personnel competence and training,
• requirements for premises, equipment and processes,
• control of storage and transport conditions,
• procedures for complaints, returns and handling of non-conforming products,
• customer qualification and supply control.

One of the important areas of these guidelines is precisely the transport of pharmaceutical products under controlled temperature – often in the range 2–8°C or 15–25°C.

Certification of transport equipment – the role of conformity assessment bodies

GDP certification may cover both the entire enterprise and specific means of transport. This type of conformity assessment is carried out by certification bodies operating on the basis of standard PN-EN ISO/IEC 17065:2013-03 and certification schemes compliant with PN-EN ISO/IEC 17067:2014-01. In Poland, the accrediting body for such organisations is the Polish Centre for Accreditation (PCA).

Accredited vs non-accredited certification – what does it mean?

In the article the authors present a detailed comparison of two types of certification:

Accredited certification	Non-accredited certification
Internationally recognised	No guarantee of recognition
Subject to PCA oversight	No independent oversight
Possibility of certifying legally regulated areas	No such possibility

Accredited certification is not only a higher quality standard – it is also a competitive advantage and a gateway to international markets.

What does the transport equipment certification process look like?

The certification process, as described in the article, comprises the following steps:

1. Submission of an application together with the required documentation,
2. Review of the application and signing of a certification agreement,
3. Assessment of technical documentation, including:
   • ATP certificate (or equivalent document),
   • certificates of temperature recorders,
   • leak-check documents for refrigeration units,
   • report from temperature mapping (temperature distribution study),
4. Certification decision after the final review,
5. Issuance of the certificate and commencement of surveillance of its validity.

Temperature mapping – a key test in certification

Temperature mapping is the process of determining how temperature is distributed in the vehicle cargo space. These requirements are set out in standard PKN-DIN SPEC 91323:2019-08, which also includes disturbance scenarios (e.g. door opening, unit failure). Testing should be performed by an accredited laboratory.

Standards and reference documents used in the assessment:

• PN-EN 12830:2018-09 – requirements for temperature recorders,
• PN-EN 13486:2024-06 – periodic verification of thermometers,
• PN-EN 17066-1:2019-10 – insulated means of transport,
• PN-ISO 1496-2:2020-10 – thermal containers,
• EU Regulation 2024/573 – on fluorinated greenhouse gases (leak checks of refrigeration units),
• ATP Agreement – for the carriage of perishable foodstuffs (important, but not sufficient for pharmaceuticals).

What else should the equipment of a means of transport include?

A vehicle used for the transport of medicines must include:

• temperature recording systems (with appropriate accuracy and control),
• refrigerating and/or heating units with controlled leak tightness,
• technical documentation and operating instructions,
• cleaning agents and procedures protecting against contamination.

Who is this topic for?

GDP-compliant certification is a key topic for:

• transport companies providing cold-chain services,
• pharmaceutical wholesalers and medicine distributors,
• manufacturers of refrigerated vehicles and containers,
• quality officers and GDP/GMP auditors,
• laboratories performing mapping tests.

Summary

Conformity of transport equipment with Good Distribution Practice requirements is today not only a regulatory matter, but above all a real contribution to the safety of pharmacotherapy. Through certification of vehicles, containers and refrigeration systems, it is possible to ensure the continuity and quality of the medicine supply chain – from manufacturer to patient.