Assess product quality in simulated study under the worst-case conditions in terms of shaking, vibration, shock, pressure, and temperature based on the shipping route and method(s) of transport. Demonstrate shipping of commercial packaging are capable of maintaining the recommended temperature for minimum and maximum load along the worst-case shipping route.
- Identify simulation studies to demonstrate drug product quality.
- Compare EU shipping studies to US and explain value to FDA.
- Author simulation study and prepare management to gain approval.
- Mapped supply chain and created process flow diagram. Designed distribution profiles and test plan.
- Reviewed EU distribution testing and summarized applicability to US cold chain.
- Authored proposed protocol and prepared management team for FDA meeting. Approach was approved.