{"id":3486,"date":"2026-05-25T20:57:53","date_gmt":"2026-05-25T18:57:53","guid":{"rendered":"https:\/\/www.kelvin-solutions.com\/2026\/05\/25\/cold-chain-and-regulations-what-the-gdp-says-in-2026\/"},"modified":"2026-05-26T07:55:19","modified_gmt":"2026-05-26T05:55:19","slug":"cold-chain-and-regulations-what-the-gdp-says-in-2026","status":"publish","type":"post","link":"https:\/\/www.kelvin-solutions.com\/en\/2026\/05\/25\/cold-chain-and-regulations-what-the-gdp-says-in-2026\/","title":{"rendered":"Cold chain and regulations: what the GDP says in 2026"},"content":{"rendered":"\t\t
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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. <\/p>

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? <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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The GDP regulatory framework: a refresher on the basics<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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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. <\/p>

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.<\/p>

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.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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What the GDPs are specifically calling for in 2026<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tEnd-to-end traceability\t\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/h3>\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t

\n\t\t\t\t\t\tGood Distribution Practice (GDP) requires full traceability of medicines throughout their distribution chain. This includes storage and transport conditions, with particular attention paid to temperature.\nEvery 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.\nPaper-based systems or manual records are becoming increasingly difficult to justify to inspectors. By 2026, automatic digital recording had become the expected standard. \t\t\t\t\t<\/p>\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tDocumented management of temperature deviations\t\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/h3>\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t

\n\t\t\t\t\t\tA fluctuation in temperature during transport does not automatically mean the product is spoiled. What is assessed is your ability to: \n\n
- detect the discrepancy in real time or as soon as possible,\n
- document the event in detail (time, duration, magnitude),\n
- carry out an impact assessment on the product\u2019s stability,\n
- make a well-considered and reasoned decision (release or quarantine).\n\n
Without a formalised procedure and reliable data, this demonstration is impossible. And without this demonstration, the product cannot be legally released. \t\t\t\t\t<\/p>\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tThe accreditation of transport operators and service providers\t\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/h3>\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t

\n\t\t\t\t\t\tThe GDPs are clear: any service provider involved in the supply chain must be qualified. In practical terms, this means: \n\n
- a written quality agreement between the client and the service provider,\n
- a documented assessment of the carrier\u2019s technical capabilities,\n
- regular audits, with an action plan in the event of non-compliance,\n
- proven training of the staff involved.\n\nThis 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. \t\t\t\t\t<\/p>\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tManagement of returns and product recalls\t\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/h3>\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t

\n\t\t\t\t\t\tGood 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. \t\t\t\t\t<\/p>\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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Key areas of focus during ANSM inspections<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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According to published inspection reports and feedback from the field, the most common observations relate to:<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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