When submitting a DMF application, is it acceptable to submit only a batch manufacturing record and not performing the process validations using three industrial batches?

刊登日期:2020-07-23  |  點閱次數 : 1245 次 

The process validation report may be replaced by the representative batch manufacturing record while DMF application. However, the manufacturing process should be fully validated. The process using three consecutive drug substance batches should be carried out and the report should be retained in the manufacture site for future inspection.(Referenced the API/DMF Technical Document Checklist annexed to the Announcement DOH 1021400426 (署授食字第1021400426號公告之附件「原料藥主檔案技術性資料查檢表」)



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