Prior to 2018, ophthalmic drug products (ODPs) and parenteral drug products (PDPs) underwent similar processes for Extractables and Leachables (E&L) testing. However, significant differences between ODPs and PDPs, such as the route of administration, toxicological endpoints, and the nature of their container closure systems, necessitate a distinct approach for E&L testing of ODPs.
ODPs require a specific study design due to their unique characteristics. For instance, low-density polyethylene containers, commonly used for ophthalmic solutions, can allow volatile and semi-volatile compounds to migrate through the material, potentially compromising product safety. This migration necessitates the inclusion of secondary and even tertiary packaging components in the E&L risk evaluation to ensure comprehensive safety assessments.
The lack of consensus on the toxicological limits for leachables in ODPs further complicates the testing process. As scientific knowledge on E&L testing continues to evolve and regulatory expectations shift, the industry faces increasing uncertainty regarding the appropriate approach to qualify packaging systems for ODPs.
This webinar will address the best practices and challenges associated with designing an E&L study specifically for ODPs. Attendees will learn about the critical factors to consider, such as the inclusion of various packaging components in the risk evaluation and the unique testing requirements for different types of packaging materials.
The presentation will also highlight the evolving regulatory landscape and the need for continuous adaptation to meet new standards and expectations. By understanding these complexities and implementing a tailored E&L testing strategy, manufacturers can better ensure the safety and efficacy of their ophthalmic drug products.
Participants will gain valuable insights into the latest methodologies and industry practices for conducting E&L studies on ODPs. This knowledge is essential for navigating the regulatory environment and achieving compliance with current and future standards.