What does a WDA holder have to qualify & validate ? Their processes, procedures, equipment, packaging, transport, service providers etc.
They have to calibrate equipment and temperature data loggers , balances etc.
Validation, qualification and calibration are not just one-off activities, must be carried out on an on-going basis. The must be carried out before a SOP , a piece of equipment or packaging materials are used, and they should be repeated when anything is changed to ensure ongoing compliance.
Qualification of equipment and machinery, is often described as :
- Installation qualification (IQ) is performed for new equipment,
- Operation qualification (OQ) and
- Performance qualification (PQ) monitor the day-to-day running of that equipment.
Qualification & Risk assessment of a new supply chain route, may involve investigating the route and looking for the risk and challenges along the route, it would include ….
- Requirements of the product
- Details of the validation of the packaging and /or temperature maintained truck
- Details of the temperature data logging equipment
- Details of the transport provider
- Location of the hubs if required
- The length of the delivery
- Ambient Temperature expected during the delivery
The risks should be qualified and rated and mitigating steps taken if required.
It is hard to validate a new transport route as there are often so many variables !!! If this is the case then a calibrated temperature data logger should be added to the shipment to verify the shipment was transported in a compliant manner.
Written by Jackie Peck