Regulations governing the cold chain are becoming increasingly stringent. Good Distribution Practices (GDP) provide the framework for all parties involved in the transport, storage or distribution of medicines in Europe.
But what exactly does this framework entail in 2026? What obligations apply to your business? And, above all, what are the key areas of focus during inspections?
The GDP regulatory framework: a refresher on the basics
The European GDPs are set out in Directive 2013/C 343/01, published by the European Commission. They apply to all parties involved in the distribution chain for medicinal products for human use: wholesalers, carriers, logistics providers, and also manufacturers in their capacity as distributors.
In France, their implementation is overseen by the ANSM (French National Agency for Medicines and Health Products Safety), which carries out regular inspections and may impose penalties in the event of non-compliance.
By 2026, the basic regulatory framework had not been overhauled, but the European authorities had tightened their requirements in three areas in particular: digital traceability, deviation management, and the qualification of supply chain partners.
What the GDPs are specifically calling for in 2026
End-to-end traceability
Good Distribution Practice (GDP) requires full traceability of medicines throughout their distribution chain. This includes storage and transport conditions, with particular attention paid to temperature. Every shipment of temperature-sensitive products must be accompanied by continuous, time-stamped temperature recording data that is archived. The data must cover the entire journey without interruption and be available upon request by the authorities. Paper-based systems or manual records are becoming increasingly difficult to justify to inspectors. By 2026, automatic digital recording had become the expected standard.
Documented management of temperature deviations
A fluctuation in temperature during transport does not automatically mean the product is spoiled. What is assessed is your ability to:
- detect the discrepancy in real time or as soon as possible,
- document the event in detail (time, duration, magnitude),
- carry out an impact assessment on the product’s stability,
- make a well-considered and reasoned decision (release or quarantine).
Without a formalised procedure and reliable data, this demonstration is impossible. And without this demonstration, the product cannot be legally released.
The accreditation of transport operators and service providers
The GDPs are clear: any service provider involved in the supply chain must be qualified. In practical terms, this means:
- a written quality agreement between the client and the service provider,
- a documented assessment of the carrier’s technical capabilities,
- regular audits, with an action plan in the event of non-compliance,
- proven training of the staff involved.
This point is often overlooked. A regular, reliable carrier may well fail to meet the formal requirements for GDP compliance, thereby exposing its client to regulatory risk.
Management of returns and product recalls
Good Distribution Practice (GDP) also governs product return and recall procedures. Any returned medicinal product must be isolated and assessed, and may only be returned to the marketable stock following explicit validation based on traceable data, including the transport conditions since the return.
Key areas of focus during ANSM inspections
According to published inspection reports and feedback from the field, the most common observations relate to:
- The lack of continuous temperature data: A single reading at the start and end of the journey is not sufficient. The data must be recorded continuously throughout the entire journey.
- Failure to implement deviation management procedures: The procedure is set out in the documentation but is not followed in practice, or is not known to the operators concerned.
- Missing or incomplete contracts with carriers: In the absence of a formal contract, the principal is liable in the event of an incident.
- Inadequate record-keeping: GDP regulations require data to be retained for at least one year after the medicine’s expiry date, and for a minimum of five years. Deleted or inaccessible data constitutes a critical non-compliance.
What this means for your organisation
Achieving compliance with GDP is not a one-off exercise. It is a system that must be maintained over the long term, based on three pillars:
Reliable tools for recording and transmitting temperature data in real time, without interruption and with no possibility of tampering.
Clear procedures that are known and followed by everyone involved in the process, from frontline staff to quality managers.
Comprehensive, well-organised documentation that can be accessed quickly in the event of an inspection or incident.
How Kelvin Solutions helps you meet GDP requirements
Kelvin Solutions offers temperature loggers and monitoring solutions designed to meet current GDP requirements:
- Continuous, time-stamped recording throughout the entire journey, with a report that can be exported in PDF or CSV format for your quality records.
- Real-time alerts when thresholds are exceeded, enabling action to be taken before the product is compromised and the incident to be documented as soon as it is detected.
- Archived and secure data, accessible at any time for your audits and quality reviews.
- Support with equipment qualification and the drafting of associated protocols.
In summary
Good Manufacturing Practice (GMP) requirements in 2026 remain unchanged in substance, but their implementation is being scrutinised with increasing rigour. Digital traceability, deviation management and the qualification of contractors: these are the three key areas on which inspections are focusing.
If you’re unsure about your current level of compliance, now is the right time to assess it yourself before an audit does it for you.
Please contact Kelvin Solutions to discuss your cold chain traceability requirements.
Sources:
- EUR-Lex: ec.europa.eu/health/documents/eudralex → Volume 5, Guidelines on Good Distribution Practice
- EMA: ema.europa.eu → ‘Good Distribution Practice’ section
- ANSM: ansm.sante.fr → Inspections and Best Practice section
Kelvin Solutions, 41 rue de l’Église Saint-Augustin, 33000 Bordeaux, France. +33 (0)1 86 86 22 37
