Definition: South African regulatory authority for medicines, medical devices, and in-vitro diagnostics. Enforces GDP (Good Distribution Practice) requirements for pharmaceutical cold chain.
Cold Chain Responsibilities:
- Pharmaceutical distribution licensing
- GDP compliance enforcement
- Temperature excursion reporting
- Product recall coordination
- Import/export permits
GDP Requirements: (enforced by SAHPRA):
- Temperature mapping and validation
- Qualified equipment (IQ/OQ/PQ)
- Continuous temperature monitoring
- SANAS-calibrated sensors
- Deviation investigation
- Staff training documentation
Why It Matters: Pharmaceutical distributors must hold SAHPRA wholesale license, which requires demonstrated GDP compliance including cold chain controls.
Related Terms: GDP, Pharmaceutical Cold Chain, Temperature Mapping, Qualified Transport
Resources: GDP Compliance Guide
Find Services: GDP-compliant pharmaceutical distributors and consultants