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