Definition: Refrigerated transport vehicles that have been validated (IQ/OQ/PQ) to consistently maintain pharmaceutical temperature requirements (+2°C to +8°C) under all operating conditions.
Qualification Requirements:
- Temperature mapping (empty and loaded)
- Worst-case testing (maximum ambient temperature, door openings)
- Temperature distribution study
- Continuous temperature monitoring
- Regular requalification (annually typical)
Documentation:
Qualification reports must demonstrate temperature uniformity and stability meeting pharmaceutical requirements.
Why It Matters:
- GDP compliance requirement
- SAHPRA licensing requirement
- Pharmaceutical manufacturer requirement
- Patient safety assurance
Related Terms: GDP, IQ/OQ/PQ, Temperature Mapping, Pharmaceutical Compliance
Find Services: Qualified pharmaceutical transport providers