Review current vendor data, provide recommendations on shipping temperature sensitive (primarily 2-8°C) products via ocean containers and validate the process. Combine key equipment, data and specifications essential for container qualification and shipping process validation using a bracketing strategy.
- Conduct a risk assessment of ocean shipping process.
- Assess manufacturer qualification, testing data, and specifications.
- Create a validation master plan based on risks and regulations.
- A technical report of strengths and weaknesses of testing data, steamship companies, and/or freight forwarders.
- Product testing strategy and VMP for ocean transport of temperature-sensitive drug product.
- Performance qualification protocol and report for ISO containers to ship temperature sensitive drugs worldwide.