Extractables and leachables testing is an essential and integral part of qualifying combination product packaging and delivery systems during drug development. With combination products, there are typically multiple elements that comprise the device and/or packaging – and all must be meticulously studied to ensure compliance with regulations requiring sufficient data and information to prove that the packaging system chosen maintains the quality, sterility and efficacy of the product. The materials of the combination products packaging may contain extractables that can leach into drug the products and may significantly impact development processes. There are different sources of extractables and leachables that need to be considered and evaluated.
The process of determining an appropriate approach for extractables and leachables testing for a combination product starts with an extractable assessment to understand and ensure all materials are characterized appropriately. During this step it’s very important to set accurately the most critical parameters to be included in the technical assessment.
Leachables testing is a mandatory step for combination products. The assessment is usually performed on real stability samples when available and techinically possible considering the ingredients of the formulation.
During this live webinar we will showcase the most relevant testing challenges, the most appropriate analytical techniques to be employed, the reporting threshold to be applied, the number of check points necessary and all the important information to be shown to regulatory authorities and notified bodies. Our experts will provide valuable insights on how to set-up proper studies, and analysis of extractables and leachables that will serve an essential function during drug and device development.
Thanks to our outstanding experience in the field we will discuss real case studies to help clients understand how extractables and leachables can be most effectively managed through timely and meticulous evaluation and testing.