Good Distribution Practice (GDP) is the set of standards that governs how medicinal products are stored, transported and handled across the distribution chain so their quality and integrity are maintained from manufacturer to patient.
Good Distribution Practice (GDP) is the set of standards that governs how medicinal products are stored, transported and handled across the distribution chain so that their quality and integrity are preserved from the manufacturer to the patient. In the EU, GDP for human medicines is defined by the European Commission guidelines 2013/C 343/01.
At its core, GDP is about evidence: continuous temperature control of storage and transport, a documented audit trail, prompt detection and handling of deviations, and the ability to retrieve complete records for an inspector. Seemoto is built to support exactly these requirements — automating the data capture and reporting that GDP demands while leaving the quality decisions where they belong, with your team and your Responsible/Qualified Person.
What GDP requires
Continuous temperature control
Storage and transport conditions must be controlled and monitored throughout the distribution chain, not spot-checked.
Temperature mapping
Storage areas must be mapped before use under representative conditions to identify hot and cold spots, then re-assessed on a risk basis and after significant changes.
Documented audit trail
All monitored conditions, deviations and corrective actions must be recorded and retained for an appropriate period.
Deviation management
Excursions must be detected promptly, investigated, and supported by documented corrective action and impact assessment.
Data retrieval for inspection
Complete historical records must be retrievable and exportable for regulatory review at any time.
How Seemoto supports GDP
Continuous automated logging
Wireless sensors log continuously at a default 5-minute interval (configurable to 1 minute), eliminating manual log-book gaps.
Real-time deviation alerts
SMS and email alerts fire the moment a reading crosses a configured threshold, with multi-tier escalation so the right person responds.
Tamper-evident audit trail
Every measurement is time-stamped at the point of capture and stored in a tamper-evident cloud record with 5-year retention as standard.
Mapping-informed sensor placement
Seemoto's temperature mapping service identifies the hot and cold spots GDP requires permanent monitoring to cover.
Audit-ready reports
Compliance reports export to PDF, CSV and XLS with min/max/mean values, calibration status, deviation history and corrective-action records for QP review.
What's included vs. what's a service
Transparency matters in regulated buying. Here is exactly what comes with a standard Seemoto monitoring subscription, and what is delivered as a separately scoped professional service.
Included by default
- Continuous data logging at 5-minute intervals
- 5-year secure cloud data retention
- Real-time SMS and email alerts
- Standard audit-ready compliance reports
- Full historical data access and export
- Per-device factory calibration certificate
Professional services (scoped separately)
- IQ/OQ/PQ validation documentation
- Temperature mapping / qualification studies
- Signed and validated audit report packages
- On-site audit preparation and support
- Periodic recalibration with updated certificates
Documents Seemoto provides
- Per-device calibration certificates (digital, on demand)
- Chain-of-custody history for monitored assets
- Pre-built regulatory audit reports with timestamps
- System architecture documentation
Where GDP applies
Primary sectors: Pharma wholesale & distribution · 3PL cold chain · Hospital supply chains · Pharmacies
Frequently asked questions
Seemoto provides the continuous monitoring, tamper-evident audit trail and audit-ready reporting that GDP requires, which removes the largest practical compliance burden. GDP compliance itself is achieved by your whole quality system — procedures, trained staff, a Responsible Person and validated processes. Seemoto supports those requirements; it does not certify your operation.
GDP does not mandate a single fixed interval; it requires continuous monitoring sufficient to detect excursions and demonstrate control. Seemoto logs at a default 5-minute interval, configurable down to 1 minute for critical areas, and alerts in real time when thresholds are breached.
Yes. EU GDP requires storage areas to be mapped before use under representative conditions, repeated on a risk basis and after significant changes. Seemoto offers temperature mapping as a professional service, delivering a compliant report with hot/cold-spot analysis and permanent sensor placement recommendations.
Seemoto retains monitoring data for 5 years as standard, with longer retention available. All records are time-stamped at capture, tamper-evident, and exportable as PDF, CSV or XLS for inspection at any time.
No. Formal IQ/OQ/PQ validation documentation is a separate professional service, scoped to your regulatory requirements. The standard monitoring subscription includes continuous logging, alerting, retention and audit-ready reports, but not validation.
GDP guides & resources
Practical, vendor-neutral guides related to GDP compliance and temperature monitoring.
GDP Warehouse Compliance: A Step-by-Step Guide
The practical building blocks of a GDP-compliant warehouse: mapping, monitoring, deviations, calibration and the documentation an inspector will ask for.
Read guide →Temperature Mapping: A Practical Guide for Warehouses, Cold Rooms & Vehicles
What temperature mapping is, when it's required, how many sensors you need, how long to run a study, and what a compliant mapping report must contain.
Read guide →Managing Temperature Excursions: A Decision Framework
A step-by-step framework for handling a temperature excursion: detect, contain, assess impact with stability data and MKT, decide, and document.
Read guide →References & further reading
- EU Guidelines on Good Distribution Practice (2013/C 343/01)
- EN 12830:2018 — Temperature recorders for transport, storage and distribution
This page is general guidance, not regulatory or legal advice. Seemoto supports the requirements these frameworks enforce; achieving compliance depends on your full quality system. Confirm specific obligations with your competent authority or quality team.
Other compliance topics
Talk to us about GDP monitoring
Tell us about your environment and compliance goals. We'll map your requirements to the right monitoring setup and confirm any validation or documentation scope up front.