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Post on 19-Feb-2017



Health & Medicine

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DMF Submission Requirements


DMF Submission TheDrug master file(DMF) requirements are defined by the US FDA in various guidelines. The DMF requirements related to format and assembly of DMF is discussed in the below points:The original and duplicate copies must be collated, fully assembled, and individually packed. Each volume of a DMF should be, not more than 2 inches thick. For multivolume submissions, number each volume For Eg: 1 of 3, 2 of 3, and 3 of 3 etc.,An original and duplicate copy need to be submitted for all DMF submissions. Drug Master File (DMF) holders and their agents/representatives should retain a complete reference copy that is identical to the one which is given forUS FDA DMF submission.

DMF RequirementsThe following are the DMF requirements for submitting the DMF to US FDA:For printing the DMF, US standard paper size (81/2by 11 inches) is preferred. Paper length should not be less than 10 inches nor more than 12 inches. However, it may occasionally be necessary to use individual pages larger than standard paper size to present a floor plan, synthesis diagram, batch formula, or manufacturing instructions. Those pages should be folded in such a way to allow the page to be opened for review without any damage to the DMF and refolded easily.The DMF files left margin should be at least three-fourths of an inch to assure that text is not obscured in the fastened area. The right margin should be at least one-half of an inch. The DMF submitter should punch holes 81/2inches apart in each page.