The Complete GDP Cold Chain Compliance Checklist for 2026

Good Distribution Practice (GDP) audits are among the most rigorous inspections in the pharmaceutical supply chain. Whether you are a wholesaler, third-party logistics provider, or hospital pharmacy, demonstrating unbroken temperature control across storage and transit is not optional — it is a legal requirement under EU GDP guidelines (2013/C 343/01).

This checklist distills the key temperature-monitoring requirements into actionable steps you can verify before every audit. Use it as a self-assessment tool to identify gaps and strengthen your cold chain compliance posture.

1. Temperature Mapping and Qualification

Before you can monitor, you must understand the thermal profile of every storage area:

• Perform temperature mapping for all warehouses and cold rooms (GDP §9.2)
• Repeat mapping after any HVAC modification, layout change, or new racking installation
• Document hot spots and cold spots; place monitoring sensors accordingly
• Validate mapping results against product storage requirements (2–8°C, 15–25°C, etc.)

2. Monitoring Equipment Requirements

Your recording devices must meet specific technical standards:

• Use calibrated temperature recorders with traceable calibration certificates (ISO 17025 preferred)
• Recording interval ≤ 15 minutes for storage, ≤ 5 minutes recommended for transport
• Devices must be EN 12830 compliant for transport applications
• Maintain a device inventory with serial numbers, calibration dates, and next-due dates
• Ensure backup recording capability if primary system fails

TERMOGRAF TG5 satisfies all these requirements: calibrated with a traceable certificate, configurable recording intervals, EN 12830 compliant, and operates as an independent backup to any real-time system.

3. Calibration Management

Calibration is the cornerstone of data integrity:

• Calibrate all temperature sensors at least annually (or per manufacturer recommendation)
• Use accredited calibration laboratories with ISO 17025 scope for temperature
• Store calibration certificates in a controlled document management system
• Define acceptance criteria (e.g., ±0.5°C at tested points)
• Have a procedure for handling out-of-tolerance findings (impact assessment, re-qualification)

4. Alert and Excursion Management

Detecting excursions is only valuable if you can respond in time:

• Define alarm thresholds for each storage zone (both warning and critical levels)
• Ensure 24/7 alert notification capability — SMS, email, audible alarm, or all three
• Document response procedures: who is called, within what timeframe, escalation path
• Log all excursions with root cause analysis and corrective actions
• Review excursion trends quarterly to identify recurring issues

5. Transport Monitoring

GDP guidelines extend beyond warehouses to every segment of distribution:

• Equip all distribution vehicles with temperature recording devices
• Verify temperature records at dispatch and receipt — TERMOGRAF's instant printout is ideal for this
• Qualify packaging and insulated containers for the planned duration and seasonal extremes
• Define maximum transit times based on qualification data
• Back-up procedures for vehicle breakdown: contact list, alternative transport, maximum exposure time

6. Documentation and Record Keeping

If it is not documented, it did not happen:

• Retain all temperature records for at least 5 years (GDP §4.2)
• Ensure electronic records comply with data integrity principles (ALCOA+)
• Maintain SOPs for monitoring, calibration, excursion management, and device handling
• Keep an audit trail for any changes to monitoring system parameters
• Periodic review (at least annual) of all monitoring-related documentation

7. Personnel and Training

• All staff handling temperature-sensitive products must receive GDP training
• Training records must include scope, date, trainer name, and competency assessment
• Refresher training at least every 2 years or when procedures change
• Designated Responsible Person must oversee GDP compliance

Audit Preparation Checklist Summary

#	Check Item	Status
1	Temperature mapping current and documented	☐
2	All monitoring devices calibrated within validity	☐
3	Calibration certificates accessible and filed	☐
4	Alert thresholds defined for all zones	☐
5	24/7 alert notification tested and functional	☐
6	Excursion log up to date with RCA	☐
7	Transport vehicles equipped with recorders	☐
8	Records retained ≥ 5 years, ALCOA+ compliant	☐
9	SOPs current, reviewed, and signed	☐
10	Personnel training records complete	☐

This checklist is not exhaustive — always consult the full EU GDP guidelines (2013/C 343/01) and your national competent authority requirements. However, if you can tick every box above, you are well-prepared for your next audit.