GDP 2013/C 343/01: Ghid Complet pentru Monitorizarea Temperaturii în Distribuția Farmaceutică

The European Union's Good Distribution Practice guidelines (2013/C 343/01) set the gold standard for pharmaceutical supply chain integrity. Chapter 9, "Transportation," is where temperature monitoring becomes a legal obligation — not just a best practice. This guide explains what the regulation actually requires and how TERMOGRAF TG5 helps you comply at every step.

Understanding GDP 2013/C 343/01

GDP applies to all parties in the pharmaceutical distribution chain: manufacturers, wholesale distributors, third-party logistics providers, and even hospitals that store and distribute medicines. The key principle is simple: the quality of a medicinal product must not be compromised during distribution.

For temperature-sensitive products (which includes most biologics, vaccines, and many common medications), this means maintaining documented temperature control from the point of manufacture to the point of patient use.

What GDP Says About Temperature Monitoring

The relevant sections of GDP 2013/C 343/01 include:

• §9.2 (Storage) — premises must be equipped with temperature monitoring devices, placed according to a documented temperature mapping study
• §9.3 (Transport) — equipment used for monitoring during transport should be maintained and calibrated at regular intervals
• §9.4 (Temperature control) — the required storage and transport conditions must be maintained at all times; deviations must be documented and investigated
• §3.3 (Training) — personnel involved in distribution must be trained on GDP requirements, including temperature monitoring procedures

Common Audit Findings

Based on published regulatory inspection reports, the most frequent temperature-related GDP non-conformities are:

1. Expired calibration certificates — the #1 finding, often a critical non-conformity
2. Incomplete temperature mapping — mapping not repeated after facility changes
3. No excursion investigation — temperature deviations detected but not documented or investigated
4. Gaps in transit monitoring — vehicles not equipped with recording devices, or records not checked at receipt
5. Inadequate alert systems — alarms not functioning or no out-of-hours coverage

How TERMOGRAF TG5 Addresses Each Requirement

GDP Requirement	TERMOGRAF Solution
Continuous temperature recording	Configurable intervals (1–60 min), non-volatile memory
Calibrated equipment	Ships with traceable calibration certificate; annual recal available
Documented proof at receipt	Built-in thermal printer produces report in seconds
Data integrity / tamper-proof	Protected non-volatile memory, no user-editable data
Real-time alerting (where needed)	SensorsReport add-on for cloud dashboard + alerts

Implementation Best Practices

1. Start with mapping — perform temperature mapping in all storage areas before deploying loggers
2. Deploy TG5 at critical points — warehouse hot/cold spots, vehicle cargo area, shipping containers
3. Train your team — ensure all logistics staff know how to start, stop, and print from the TG5
4. Check at every handover — print the temperature report at dispatch and receipt; both parties sign
5. Archive digitally — download data via USB; store PDFs alongside your batch documentation
6. Calendar calibration — set reminders 30 days before certificate expiry

Beyond GDP: WHO and International Requirements

If you distribute medicines internationally, you will encounter WHO Technical Report Series 961, Annex 9 ("Model guidance for the storage and transport of time- and temperature-sensitive pharmaceutical products"). Its requirements align closely with EU GDP, with additional emphasis on risk management and qualification of shipping lanes. TERMOGRAF TG5 satisfies both frameworks.