PDA Survey: 2025 Transportation Validation Benchmarking Survey

This survey aimed to gather industry benchmarking data on transportation qualification strategies within the pharmaceutical and biopharmaceutical industry. Specifically, the goal was to examine the application of simulated data to better understand how transportation conditions impact drug product quality, emphasizing the importance of ensuring product quality during transit. The survey focused on evaluating transportation through simulated environments versus real-world qualification of temperature-controlled shipping systems.　　

The overarching goal is to evaluate the use of simulated data as a reliable source for regulatory submissions as opposed to conducting real-world studies, which require time and resources that can often delay approvals. Ultimately, those delays can prevent patients from receiving critical medicines in a timely manner. In addition, through the results of this survey, the industry aims to identify opportunities for improving supply-chain efficiency through the use of predictive models. With the increasing use of digitization and artificial intelligence across multiple industries, more consideration should be given to the use of predictive models.　

To contextualize responses, the survey included general demographic questions and was structured into product-specific, supply-chain-focused, and regulatory strategy-driven categories. The manufacturers of small molecule medicines and oral dosage forms were not a target audience for this survey.