This presentation will describe a QbD approach to the selection of materials used to package drug products or to construct medical devices that deliver drug products. Special attention is required for materials that contact drug products due to extractables and leachables (E&L) considerations. Leachables, chemicals that migrate from the materials into the drug product, can cause safety toxicity concerns and/or stability issues from unwanted reactions with the drug product. Testing is required to demonstrate the quality of the drug product at end-of-shelf-life. To meet global supply requirements, a shelf-life period of 2 or more years is normally desired. A miss-step in the selection of packaging or device materials can lead to costly material change issues and delayed launch schedules if detection of unwanted leachables occur during late stage testing.
This presentation outlines a QbD E&L process for materials that are normally purchased for packaging or device purposes. The process can reduce the risk of poor choices in materials due to E&L issues. The presentation will include examples and will discuss industry initiates currently under development to help in the material selection, testing, and evaluation of extractables and leachables.&'
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