By Wayland Rushing, Ph.D., Allan R. Moorman, Ph.D.
Purpose: Extractables and Leachables (E&L) is a challenging topic to address during product development. A successful E&L program depends on whether the program design is based on the correct information on the container/closure system. The first critical step is the initial material characterization (determination of extractables) of the container/closure system to understand what can possibly migrate into the final drug product as a leachable. If the data from these studies is not applicable or insufficient for a sponsor’s product, it can lead to regulatory delays or recalls. Most of the container/closure systems used today are not proprietary but are purchased from component manufacturers. As part of a service to their clients, many of these providers now offer extractable information on their products. However, the usefulness of this information can vary widely from manufacturer to manufacturer. The challenge for sponsors is to understand what information they need, what questions to ask their vendors, and how to evaluate the information for their specific application. This presentation will walk through a process for ensuring the right questions are asked and how that information should be evaluated.
Methods: A stepwise process will be presented that will enable companies to ensure they are asking the correct questions when interacting with their container/closure vendors. An example risk assessment and gap analysis process will be presented that covers how the data can be evaluated against a sponsor’s specific drug product.
Results: Representative case studies will be presented in applying the process to data provided by the component manufacturer.
Conclusions: By starting the extractables and leachables evaluation early, sponsors can avoid potential delays in their development time line, avoid recalls and, most importantly, avoid jeopardizing patient safety.
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