Good Distribution Practice (GDP) governs how medicinal products are stored and handled so their quality is preserved up to the point of dispensing. In the EU it is defined by the European Commission guidelines 2013/C 343/01. For a warehouse, GDP compliance comes down to a handful of practical disciplines — and most of them revolve around temperature control and the evidence that proves it.
This guide walks through the building blocks of a GDP-compliant warehouse and what an inspector typically expects to see for each. It is general guidance; your Responsible Person (RP) and quality system define how these apply to your site.
Know the temperature zones you must hold
GDP warehouses typically operate several controlled zones simultaneously, and each must be demonstrably held within its labelled range. The most common pharmaceutical bands are ambient (15–25 °C), cold (2–8 °C) and frozen (around −20 °C), with ultra-low and cryogenic ranges where biologics are stored.
The compliance burden is to prove — continuously, per zone — that product never left its band, and to handle the moments when it did. Everything below serves that single objective.
1 · Qualify the space with temperature mapping
Before storing product, map the warehouse to identify hot and cold spots under representative conditions, and repeat seasonally and after significant changes. Mapping tells you where the worst-case locations are — and therefore where permanent monitoring sensors must go. Placing sensors at convenient locations instead of mapped worst-case points is a frequent inspection finding.
2 · Monitor continuously
GDP requires continuous control of storage conditions, not periodic spot-checks. Fixed sensors at the mapped worst-case positions should log continuously (Seemoto's default is every 5 minutes, configurable to 1 minute) and alert in real time when a reading leaves range, with escalation so an alert is never missed overnight. Local buffering in the sensor ensures no gap appears in the record during a brief connectivity outage.
3 · Handle deviations properly
When an excursion occurs, GDP expects prompt detection, containment, a documented impact assessment, a disposition decision by a qualified person, and corrective/preventive action. A good monitoring system generates the deviation record automatically — time-temperature profile, alarm history, acknowledgements — so the quality team can focus on the decision rather than reconstructing what happened.
4 · Keep equipment calibrated
Monitoring is only as trustworthy as its calibration. Sensors should carry traceable calibration certificates, and recalibration should follow your quality system's interval (often annual for pharmaceutical storage). Calibration status should be visible on compliance reports so an inspector can confirm a sensor was in tolerance during the period under review. With Seemoto, devices are factory calibrated with individual certificates, and periodic recalibration is available as a professional service.
5 · Retain and retrieve records
Inspectors will ask for historical data, deviation records, calibration certificates and proof of mapping. All of it must be retrievable on demand and retained for an appropriate period. Automated, tamper-evident cloud storage with one-click export turns an audit from a scramble into a routine task.
- Temperature mapping reports and protocols
- Continuous monitoring data with min/max/mean and full alarm history
- Deviation/excursion records with impact assessments and CAPA
- Per-device calibration certificates with status visible on reports
- System architecture and SOP documentation
What inspectors look for (and common findings)
Most GDP temperature findings cluster around a few recurring gaps. Knowing them in advance is the cheapest way to pass an inspection.
- Sensors placed at convenient spots rather than mapped worst-case locations.
- Gaps in the continuous record (connectivity outages with no local buffering).
- Excursions logged but not investigated, or closed without a real CAPA.
- Calibration overdue, or certificates that cannot be produced on the day.
- Mapping never done, or never repeated after a layout or HVAC change.
Where Seemoto fits
Seemoto supports GDP warehouse operations with continuous wireless monitoring, real-time escalating alerts, a tamper-evident audit trail with 5-year retention, and audit-ready reports — plus temperature mapping and formal validation (IQ/OQ/PQ) as professional services. As a proof point, Seemoto has supported pharmaceutical 3PL operator Signia Logistics across five distribution centres and 40,000+ storage positions in Peru since 2014. Seemoto supports the GDP requirements; achieving and maintaining compliance is the responsibility of your quality system.
Key takeaways
- GDP warehouse compliance rests on mapping, continuous monitoring, deviation handling, calibration and records.
- Hold each zone (ambient 15–25 °C, cold 2–8 °C, frozen ~−20 °C) and prove it continuously, per zone.
- Map first, then place permanent sensors at the worst-case locations the map reveals — not convenient spots.
- Deviations need a documented impact assessment, a qualified-person decision and a real CAPA — not just an alert.
- Calibration traceability and on-demand record retrieval are recurring audit focus areas; tools support compliance, your quality system achieves it.