Step Two – Validate and Verify the distribution process

Distribution is a HC regulated practice and requires a validated process to ensure shipping conditions when blood components and products are shipped in an uncontrolled environment.

An operational validation should be performed by each site using validated shipping containers to ensure the variation in transport and personnel produce the same results as validated by ORBCoN and meet the required Health Canada blood regulations.

Periodic verification of the shipping containers and the redistribution process is a requirement to ensure compliance as required by HC and ACD. ORBCoN will perform a bi-annual verification of the shipping containers and post the results for facilities to refer to as evidence that the performance of the shipping containers continues to meet the validated outcomes.