Lilly

Background

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.

Objectives

  • 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.

Results

  • 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.

Ever consider a switch to ocean transport from air transport?

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