Observed trends in regulatory expectations for the qualification of pharmaceutical container/closure systems from an extractables and leachables perspective
Question: A first observation you bring to the table is that – from a regulatory perspective – there is still a strong bias towards concerns about the quantitative aspect of E&L studies. Can you elaborate a bit more on this?
When assessing the impact of extractables or leachables from a safety perspective, there are two important pieces of information that will allow completing an in-depth toxicological assessment: the compound’s identity and its concentration or does to the patient.
