Inquiry - SUPAC evaluation for Modified Release product Contribution from Deepak Kheni written on 8/18/2010 at 09:40
Dear All, We are manufacturing ANDA Solid Oral drugs in our plant. One of the products is a Modified Release (MR) Tablet drug product in which one coating material is used for the coating of the Tablets. As per manufacturing formula submitted in CTD, the amount of coating material added is 35 % extra, which is to compensate during the coating precess. We wanted to change the quantity of coating material from extra 35 % to Extra 25 %. We have gone through the " Guidance for Industry SUPAC-MR: Modified Release Solid Oral Dosage Forms" but couldn't be able to find out which level of change is to be considered. The recent FDA guidance document "Guidance for Industry CMC Post approval Manufacturing Changes Reportable in Annual Reports" have been refereed which is stating (as per page No 5, Appendix - A, Point No 1 - Components and Composition) that this change can be reported in Annual report. We believe that the draft guidance documents as mentioned above is a current thinking of FDA and we can make a change. I am requesting you to kindly provide your views and valuable suggestion/s how to make such change. Thank you very much. Sincerely yours, Deepak Kheni Executive QA Answers to this contribution:
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