Extractable/leachable studies are an important part of the drug development process. As such, no application for a new drug with any regulatory body would be complete without the completion of E/L studies demonstrating the safety of the drug after contact with its manufacturing, packaging, and/or administration systems. Despite its importance, there is often great uncertainty as to how extractable and leachable studies for product registration should be performed. Accordingly, the goal of this presentation is to provide information relevant to studies performed that will be used to satisfy regulatory requirements. This will include a discussion of the tactical laboratory aspects of the execution of these studies as well as more general strategic considerations for the design of an E/L program for a pharmaceutical product.
Understand the studies that need to be performed within an extractable/leachable program to support the compatibility of a pharmaceutical product's manufacturing, packaging, and/or delivery systems as part of a regulatory submission.
Know what standards and guidances are available to provide information relevant to the design and execution of extractable and leachable studies.
Be aware of important details associated with the analytical work used in E/L studies in order to ensure that the data generated is accurate and representative of the system(s) and drug being tested.