Definition: The strict +2°C to +8°C temperature range required for most vaccines, biologics, and temperature-sensitive pharmaceuticals per GDP (Good Distribution Practice) requirements.
Why It Matters::
- Non-compliance can render products ineffective or unsafe
- SAHPRA regulations require continuous monitoring and documentation
- Temperature excursions must be investigated and reported
- Products may require destruction if temperature range is exceeded
Why So Strict:
- Below +2°C: Product may freeze (damage)
- Above +8°C: Product potency may degrade
- Temperature excursions may render product ineffective or unsafe
Regulatory Context: WHO GDP guidelines, SAHPRA requirements, mandatory for pharmaceutical distribution licenses.
Related Terms: GDP, SAHPRA, Temperature Excursion, Temperature Mapping, Qualified Transport
Find Services: GDP-compliant pharmaceutical cold chain providers