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FDA encourages extractable—6leachable correlations to ease post-approval changes
Summary
FDA presenters recommended that applicants submit extractable–leachable correlations because they allow QC control of extractables and simplify future compositional changes to container-closure systems.
Xing Su told attendees that while the agency does not currently require extractable–leachable correlations at the time of approval, submitting such correlations carries benefits for manufacturers. With a correlation, she said, a manufacturer can control extractables at the CCS QC stage and avoid controlling leachables in the finished drug product throughout shelf life.
"If you have the correlation, then it is a lot easier for you to, for example, make later changes to the composite composition of the CCS," Su said, explaining that comparisons of extractable data can show changes will not increase leachable risk, thereby simplifying post-approval changes.
