Good distribution practice (GDP) for a pharmaceutical warehouse is set out in WHO TRS 1025 Annex 7 (2020) and in the EU GDP Guidelines of 5 November 2013 (2013/C 343/01). Both expect a quality system with a responsible person, temperature-mapped storage, approved suppliers and customers, and written control of returns, recalls, falsified products and transport.
This guide is for responsible persons, warehouse and quality managers at pharmaceutical wholesalers, third-party logistics providers and cold-chain operators.
Which GDP texts apply to a pharmaceutical warehouse?
WHO's current text is TRS 1025 Annex 7, Good storage and distribution practices for medical products. The WHO Expert Committee adopted it to consolidate two older texts, good storage practices (TRS 908 Annex 9, 2003) and good distribution practices (TRS 957 Annex 5, 2010). It also aligned WHO guidance with EU and PIC/S standards. A guide that still names TRS 957 as the WHO GDP text is out of date.
Annex 7 applies to every entity that stores or moves medical products, from the manufacturer to the point of dispensing. WHO names wholesalers, distributors, brokers, logistics providers, transport companies and forwarding agents. It also says countries may adapt it or write their own national guidelines.
In the EU, the Guidelines of 5 November 2013 are based on Articles 84 and 85b(3) of Directive 2001/83/EC. They replaced the 1994 guidelines and a March 2013 version, and have applied since the day after their publication on 23 November 2013. Outside the EU, the authority that licenses your wholesale activity decides which text it inspects against, so confirm this before you build the system.
How do the WHO and EU texts compare on the main requirements?
The two texts cover the same ground in a different order. The table maps the points an inspector usually tests.
| Requirement | WHO TRS 1025 Annex 7 (2020) | EU GDP 2013/C 343/01 |
|---|---|---|
| Person accountable for the quality system | A designated person, preferably independent of operations (16.3) | A responsible person with twelve listed duties, including approving returns to stock (2.2) |
| Temperature mapping | Mapping of storage areas, refrigerators and freezers (12.36) | Initial mapping before use, repeated after a risk assessment or significant change (3.2.1) |
| Stock rotation | First expired, first out (12.30) | FEFO, including for returned stock (6.3) |
| Suppliers and customers | Supply only to entities authorised under national law (18.32) | Qualification of suppliers and customers (5.2, 5.3) |
| Returns | Quarantine on receipt, destroy unless quality is certain (9) | Five conditions for return to saleable stock, extra evidence for cold-chain items (6.3) |
| Transport | Vehicles qualified where applicable, conditions monitored and recorded (18.24, 18.25) | Excursions reported to distributor and recipient and investigated (9.2) |
| Self-inspection | On an annual schedule, by an unbiased team (11) | Under a programme, recorded and followed by corrective action (8) |
| Record retention | As national legislation requires | As national law requires, but at least five years (4) |
What does GDP require of the warehouse itself?
Start with the responsible person. The EU text says this person must be continuously contactable, may delegate duties but not responsibility, and decides the fate of returned, rejected, recalled and falsified products. WHO adds that managers and staff should not face commercial, political or financial pressure that could affect product quality.
Next comes the storage environment. The EU text requires an initial temperature mapping exercise under representative conditions, with monitoring probes placed where the mapping found the extremes. Monitoring equipment is calibrated at intervals based on risk (3.3), and alarms are set for excursions and tested regularly. Mapping is repeated when a risk assessment calls for it or when the building or the cooling equipment changes significantly.
Finally, the paperwork has to survive an inspection. Records are kept for the period national law sets, at least five years under the EU text. Every change to a record is signed and dated so the original stays readable.
What changes for cold-chain products?
Annex 7's Appendix 1 gives the recommended ranges behind common label wording. Store in a refrigerator means 5 ± 3 °C, store in a freezer means -20 ± 5 °C, a deep freezer means -70 ± 10 °C, and controlled room temperature means 15 to 25 °C. WHO says vague wording such as "store at ambient conditions" should be avoided.
For temperature-sensitive products in transit, the EU text expects qualified equipment such as thermal packaging, temperature-controlled containers or vehicles. Mapping of temperature-controlled vehicles should take seasonal variation into account. Cool-packs should not touch the product, frozen and chilled packs are kept apart, and staff are trained on seasonal pack-out configurations. WHO points cold-chain operators to its model guidance for time- and temperature-sensitive products, TRS 961 Annex 9 (2011).
If your business is mainly transport rather than storage, our guide to GDP for medical freight forwarding covers that side.
How should you handle a temperature excursion or a cold-chain return?
This is where inspectors spend their time, because it shows whether the system works under pressure. Under the EU text, an excursion in transit is reported to both the distributor and the recipient, and a written procedure covers investigation and handling.
A practical excursion procedure, in our interpretation, has five parts:
- Quarantine the affected stock at once, under its required storage conditions.
- Download and keep the logger data, and record the duration and peak temperature.
- Ask the marketing authorisation holder for its stability assessment before deciding.
- Have the responsible person record the decision to release, return or destroy.
- Open a deviation and corrective action, and check whether the root cause affects other shipments.
Returns of cold-chain products face the strictest test in the EU text. They go back to saleable stock only with documented evidence that the product stayed within its storage conditions the whole time. That evidence covers delivery to the customer, examination, opening and repacking, collection and return to the distributor's refrigerator. If any deviation occurred, a risk assessment has to show the product's integrity.
WHO's default is stricter still: returned products are destroyed unless their quality is certain.
Where do ISO 9001 and ISO 22301 fit with GDP?
Neither ISO standard is GDP, and an ISO certificate does not show GDP compliance. GDP is a regulatory expectation checked by the authority that licenses the wholesaler. ISO 9001 gives the management system structure, such as document control, internal audit and management review. ISO 9001:2026 was published in September 2026, so check with your certification body which edition it will audit and when.
ISO 22301:2019, amended in 2024, covers business continuity. For a warehouse this means power failure, cooling breakdown, IT outage and loss of a transport provider, each with a recovery time agreed with your principals. Our ISO 22301 guide explains the business impact analysis behind those recovery times.
How AGS can help
AGS offers two kits for this area, both in editable Microsoft Word:
- IMS Pharmaceutical Wholesaling & Warehousing (GDP, ISO 9001, ISO 22301): 57 documents, including storage, returns, recall and falsified medicines procedures, temperature logs and a GDP compliance checklist.
- IMS Cold Chain Management - CCM (GDP, ISO 9001, ISO 22301): 61 documents, including qualification and temperature mapping, excursion and transport procedures, and a mapping report form.
Frequently asked questions
Is WHO TRS 957 still the WHO GDP guideline?
No. WHO's current text is TRS 1025 Annex 7, published in 2020, which consolidated the earlier storage and distribution guidance. Update any procedure that cites TRS 957 Annex 5.
Does GDP apply to third-party logistics providers?
Yes. WHO's Annex 7 names logistics providers, transport companies and forwarding agents among the entities it applies to. Your national licensing rules decide which activities need their own authorisation.
How often must a pharmaceutical warehouse be temperature mapped?
The EU text sets no fixed interval. It requires mapping before first use, then again when a risk assessment calls for it or after significant changes to the facility or the cooling equipment.
Can a pharmaceutical warehouse get GDP certified?
GDP compliance is judged by the regulator that licenses the activity, during its inspections. A management system certificate, such as ISO 9001, is separate and does not replace that inspection.
AGS provides independent documentation toolkits. This guide refers to WHO and European Commission texts for identification only. AGS is not affiliated with, endorsed by or approved by the World Health Organization, the European Commission, any national medicines regulator or any certification body. It does not guarantee any inspection, licensing or certification outcome.
Reviewed October 2026. Facts checked against the sources current at publication.
