Good distribution practice (GDP) for medical freight forwarders comes from two main texts: WHO's Good storage and distribution practices for medical products (TRS 1025 Annex 7, 2020) and the EU GDP Guidelines 2013/C 343/01. Both expect a forwarder to keep medicines within their labelled conditions in transit, prove it with records, and work under a written contract with the distributor that hired it.
This guide is for freight forwarders, 3PLs and transport operators who move medicines for pharmaceutical clients.
Which GDP texts apply to a medical freight forwarder?
The WHO text is TRS 1025 Annex 7, published in 2020. Its introduction names transport companies and forwarding agents among the entities it applies to. WHO's list of distribution guidelines no longer includes TRS 957 Annex 5, the 2010 GDP text that many older documents still cite. The current text is on WHO's TRS 1025 Annex 7 page.
The EU text is the Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use. They were published in the Official Journal on 23 November 2013 and applied from the following day. They replaced the 1994 guidelines and a March 2013 version.
The guidelines have 11 chapters, and Chapter 9 covers transportation. The European Medicines Agency's GDP page links the text and explains how inspections and GDP certificates work.
National rules sit on top of both. Your regulator decides whether a forwarder needs a licence or registration to handle medicines, so check that first.
Is a forwarder responsible for GDP if it never owns the medicines?
Yes, through its contract. Under EU GDP Chapter 9, the supplying wholesale distributor stays responsible for protecting products and keeping temperatures within limits in transit. When a third party carries the goods, the contract must meet Chapter 7 on outsourced activities. That makes the forwarder a contract acceptor.
A contract acceptor needs suitable premises, equipment, procedures and competent staff for the work. It may not pass work to a subcontractor without the contract giver's prior approval and an audit of that third party. The contract giver audits the forwarder before work starts and whenever the outsourced activity changes. WHO TRS 1025 Annex 7 section 19 sets out a similar model, including training and periodic audits in the written contract.
In practice, every airline, trucker and ground handler you book becomes part of your client's supply chain. Your carrier qualification records are how you show a client that this chain is under control.
What does GDP require of a forwarder during transport?
Both texts focus on the same few controls. Read together, they expect the following from whoever moves the goods.
- Route risk assessment. EU GDP uses it to decide where temperature control is needed.
- Qualified equipment. Vehicles, thermal packaging and temperature-controlled containers must be shown to hold the required conditions. EU GDP asks for temperature mapping that accounts for seasonal variation.
- Calibrated monitoring. EU GDP requires temperature monitoring devices in vehicles and containers to be calibrated at least once a year.
- Transit hubs. Unloading, reloading and storage at a hub need particular attention to temperature, cleanliness and security, and waiting time should be kept short.
- Container choice. EU GDP links it to the expected external temperatures and the longest likely transit time, including customs holds.
- Deviations. A temperature excursion or damage in transit must be reported to the distributor and the recipient.
- Security. Both texts expect controls against theft and tampering. WHO also expects procedures for suspected falsified products.
For detail on temperature-controlled transport, WHO keeps technical supplements to TRS 961 Annex 9 on its list of distribution guidelines. They cover road and air transport operations, transport route profiling qualification, shipping containers and monitoring systems.
Which records will a pharmaceutical client audit?
A client or inspector tests whether each control above leaves a record. The table links the main requirements to the evidence a forwarder typically keeps. The evidence column is AGS's interpretation, not wording from either text.
| Requirement | Where it comes from | Typical record |
|---|---|---|
| Written contract defining duties | EU GDP Ch. 7, WHO TRS 1025 Annex 7 s. 19 | Quality agreement with each client, approved subcontractor list |
| Route risk assessment | EU GDP 9.2 | Lane risk assessment per route and season |
| Qualified vehicles and packaging | EU GDP 9.4, WHO TRS 1025 Annex 7 s. 18 | Vehicle and container qualification reports, temperature mapping data |
| Calibrated monitoring devices | EU GDP 9.2 | Calibration certificates at least yearly, logger records per shipment |
| Deviation reporting | EU GDP 9.2, WHO TRS 1025 Annex 7 s. 18 | Excursion report, notification to distributor and recipient, CAPA |
| Traceability and dispatch records | WHO TRS 1025 Annex 7 s. 18 | Job file, handover records, proof of delivery |
Where do ISO 9001 and ISO 22301 fit?
Neither is a GDP requirement, and whether you need either depends on your clients. ISO 9001:2026 was published in September 2026, and iso.org now lists ISO 9001:2015 as withdrawn. Certification bodies report that 2015 certificates must move to the new edition by 30 September 2029.
Confirm your dates with your certification body. Our ISO 9001:2026 transition guide explains what changed.
ISO 22301:2019, with its 2024 climate action amendment, is the business continuity standard. iso.org marks it for revision, with a new edition at committee draft stage.
For a forwarder it answers a practical question: what happens to a temperature-sensitive shipment when a flight is cancelled, a border closes or a cold store fails? A business impact analysis sets recovery times for each lane, and exercised plans prove they work. Our ISO 22301 guide covers the standard itself.
What changes for air freight?
Air shipments add more handovers and more parties. IATA's CEIV Pharma programme certifies airlines, ground handlers, airports and freight forwarders on the handling of temperature-controlled pharmaceuticals. It is built on the IATA Temperature Control Regulations. It can support your case with clients, but it does not replace the audit a contract giver carries out under EU GDP Chapter 7.
If you also store medicines between legs, warehouse GDP applies to that site. Our guide to GDP for pharmaceutical wholesaling and warehousing covers storage.
How AGS can help
The IMS Medical Freight Forwarding kit contains 61 editable Microsoft Word documents. They include an integrated manual and policy, 18 procedures such as lane risk assessment and in-transit excursion management, 24 forms and records, 7 checklists, 4 training modules and an integrated compliance matrix. The documents cite ISO 9001:2015 and WHO TRS 957 alongside EU GDP, so review them against ISO 9001:2026 and TRS 1025 Annex 7.
Frequently asked questions
Is WHO TRS 957 still the reference for GDP?
No. WHO's current guideline for storage and distribution is TRS 1025 Annex 7 (2020), and TRS 957 Annex 5 no longer appears on WHO's list of distribution guidelines.
Can a freight forwarder be GDP certified?
In the EU, competent authorities inspect wholesale distributors and issue GDP certificates. For a forwarder working under contract, EU GDP expects the contract giver to audit it. Check what your regulator and clients accept.
Who reports a temperature excursion in transit?
The party that notices it. EU GDP and WHO both expect deviations in transit to be reported to the distributor and the recipient, and investigated under a written procedure.
Does documentation make a forwarder compliant?
No. Documents describe the system. Compliance depends on how it runs and on what clients, inspectors or certification bodies find.
AGS provides independent documentation toolkits. This guide and the referenced kit are not affiliated with, endorsed by or approved by WHO, the European Commission, the EMA, IATA or ISO. They do not guarantee any audit, inspection or certification outcome.
Reviewed October 2026. Facts checked against the sources current at publication.
