When selecting and qualifying the primary packaging for lyophilized drug products (LDPs), a fundamental question arises: How extensive should the Extractables and Leachables (E&L) qualification process be? Given that the drug product is in a solid state, one might expect minimal interaction between the LDP and the components of its container. But is this really the case?
This presentation at the 2022 Nelson Labs Virtual Symposium will explore the complexities of E&L qualification for lyophilized drug products. Attendees will gain insights into the current status of regulatory requirements, learning how these standards impact the qualification process for LDP packaging.
The session will address common fallacies and misconceptions that exist in the E&L qualifications for lyophilized drug products. Participants will learn about the potential interactions between the drug product and its container components, understanding the importance of thorough E&L testing despite the solid state of the product.
Through a detailed review of regulatory expectations, the presentation will highlight best practices for conducting comprehensive E&L studies for LDPs. This includes identifying potential leachables, designing robust testing protocols, and interpreting the results to ensure the safety and efficacy of the drug product.
By examining real-world examples and case studies, attendees will understand the practical implications of E&L qualifications and how to effectively address the challenges unique to lyophilized drug products. This knowledge is crucial for ensuring compliance with regulatory standards and maintaining the quality of LDPs.
This presentation is essential for professionals involved in the development, testing, and regulatory compliance of lyophilized drug products. By attending, participants will acquire valuable insights into the E&L qualification process, helping to ensure their products meet the highest standards of safety and regulatory compliance.