Good Afternoon,
I have a question regarding the best practice for updating an analytical method for the analysis of drug product that is currently
in review and has
not gained final approval.
The firm has previously updated this method in response to a deficiency letter from the FDA, however since that time additional optimization work was performed to further strengthen the method. While the current method is acceptable, validated and meets requirements, the additional work shows that it could be improved. (Tightening of an in-process pH range) The updated method does not contradict the submitted method and only tightens in-process test limits.
The current plan is to await approval, submit the optimized method as part of an annual report following approval as a minor change (since it only improves controls). Unless of course the method is addressed again by the agency prior to that date. A few stability intervals that remain would be tested using this optimized method at the end of the shelf study.
Does this sound prudent or are there suggestions for a better route?
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Kristopher Stavely
St Petersburg FL
United States
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