Transport validation is a regulatory expectation and is required for the marketing application.

• Provides a high degree of assurance.
• Product quality is not impacted by transportation.
• Transport processes function effectively and reproducibly as intended.

Transport Validation consists of two independent work streams:

1. Shipper Qualification: Demonstrates temperature control (cold chain) in our distribution network functions effectively and reproducibly as intended.
2. Product Transport Evaluation: Demonstrates that product can be transported without adverse impact to product quality attributes