Definition: Wholesale and distribution license issued by South African Health Products Regulatory Authority (SAHPRA) required for pharmaceutical distribution operations.
Cold Chain Requirements for Licensing:
- GDP-compliant quality management system
- Temperature-controlled storage facilities (mapped and qualified)
- Qualified refrigerated vehicles
- Continuous temperature monitoring
- Calibrated equipment (SANAS-accredited calibration)
- Trained personnel
- Standard operating procedures
- Deviation reporting system
Inspection: SAHPRA inspects facilities before license issuance and periodically thereafter.
Related Terms: SAHPRA, GDP, Pharmaceutical Distribution, Regulatory Compliance