Prior to 2018, ophthalmic drug products (ODPs) and parenteral drug products (PDPs) were both treated the same way when undergoing Extractables and Leachables (E&L) testing. However, ODPs differ significantly from PDPs in terms of route of administration, toxicological end-points and the nature of their container closure system. Hence, it is needless to say that E&L testing for ODPs requires a specific study design compared to other dosage forms. For example, low-density polyethylene containers allow for volatile and semi-volatile compounds to migrate through the material into the ophthalmic solution and, as such, compromise the product’s safety. This implies that secondary packaging components and even tertiary packaging components should be included in the E&L risk evaluation. Furthermore, until now no consensus has been reached regarding the toxicological limits to be applied during the safety assessment of leachables in ODPs. Given that the scientific knowledge on E&L testing is continuously evolving, as are the expectations of the agencies, the industry is faced with an increasing uncertainty concerning what would be an adequate approach for qualifying their packaging systems. In this webinar, best practices and challenges related to the design of an E&L study for ODPs will be addressed.