Pharmazeutische Industrie
TERMOGRAF GDP solutions for pharmaceutical distribution — temperature monitoring compliant with 2013/C 343/01
GDP Compliance for Pharmaceutical Distribution
The European GDP (Good Distribution Practice) regulation 2013/C 343/01 mandates continuous temperature monitoring throughout the entire pharmaceutical distribution chain. Any undetected temperature deviation can compromise medicine efficacy, endanger patient health, and lead to significant financial losses and regulatory sanctions.
TERMOGRAF TG5 is specifically designed to meet GDP requirements, providing continuous temperature recording with a built-in thermal printer — compliance proof is available instantly, at every delivery point, without dependence on connectivity, apps, or delayed data download.
Challenges in Pharmaceutical Distribution
GDP Audits
Inspectors require documented proof of temperature monitoring at every stage of distribution. Missing documentation means non-compliance.
Single-Use Loggers
Single-use loggers create waste, high recurring costs, and data download delays that slow down verification at receiving.
Manual Recording
Manual temperature recording is prone to human error, difficult to audit, and does not meet GDP tamper-proof data requirements.
Temperature Excursions
Without temperature excursion alerts, affected batches reach patients, leading to costly recalls and health risks.
How TERMOGRAF Solves These Challenges
On-Site Printing
The thermal report prints at delivery — the pharmacist or receiving officer verifies compliance on the spot, without a computer or app.
Tamper-Proof Data
Recorded data cannot be altered after the fact — a core GDP requirement. Internal memory retains records for digital audit.
Accredited Calibration
Calibration certificate traceable to national standards, valid 12 months. Annual recalibration available.
Reusable
Unlike single-use loggers, TERMOGRAF TG5 is fully reusable — reduces costs and waste over time.
Relevant Regulations
| Regulation | Description | Requirement Met |
|---|---|---|
| EU GDP 2013/C 343/01 | Guidelines on Good Distribution Practice for medicinal products for human use | Continuous monitoring + printing |
| WHO TRS 961 Annex 9 | Storage and distribution of pharmaceutical products | Traceable calibration |
| EN 12830 | Temperature recorders for transport and storage | Certified compliant |
Recommended Models for Pharma
For standard pharmaceutical distribution, we recommend the TG5-1T model with a single temperature probe. For warehouses and storage rooms where humidity is a critical factor, the TG5-2TRH model with temperature and humidity probes is the optimal choice.