Shipping and Transportation Studies to Evaluate Drug Product Quality
Astacio González, Kristen
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Many pharmaceutical or biotechnological products require transport using temperature-controlled systems to maintain their therapeutic properties. There are presently no official guidelines for testing pharmaceutical products in order to define suitable transport specifications established by the FDA. After reviewing the current guidance documents, this study proposes a methodology to define appropriate transport conditions, while trying to keep competitive cost. This design project aims to provide a guideline to develop and design shipping & transportation studies. The design will consider critical factors such as transit time, transit routes, environmental conditions to evaluate that there is no effect on critical quality attributes (i.e., appearance and stability indicating analytical tests) of the evaluated/shipped product. Key Terms - Pharmaceutical Products, Temperature, Transport, Shipping & Transportation Studies.