DMF装订要.docVIP

IV. D. Format, Assembly, and Delivery IV.D .格式、装配和交付 IV. D.1. IV. D.1. An original and duplicate are to be submitted for all DMF submissions. 所有DMF的提交均须提交一份原件和一份副本。 Drug Master File holders and their agents/representatives should retain a complete reference copy that is identical to, and maintained in the same chronological order as, their submissions to FDA. 药物主文件持有者和他们的代理/代表应该保留一个完整的参考副本,该副本应与提交到FDA的相同，且保持同样的时间顺序。 IV. D.2. IV. D.2. The original and duplicate copies must be collated, fully assembled, and individually jacketed. 原件和副本必须经整理,完全装订,独立封面。 Each volume of a DMF should, in general, be no more than 2 inches thick. For multivolume submissions, number each volume. For example, for a 3 volume submission, the volumes would be numbered 1 of 3, 2 of 3, and 3 of 3. 一般情况下,药物主文件的每卷,不超过2英寸[ 5.08cm ]厚。如提交多卷时,将每卷编号。例如,提交3卷,则编号为3-1卷，3-2卷，3-3卷。 IV. D.3. IV. D.3. U.S. standard paper size (8-1/2 by 11 inches) is preferred. 最好使用美国标准纸张大小(8-1/2×11英寸)。 [ 纸张规格：letter。 纸张大小：21.59cm×27.94cm 陈强备注 ] 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 and mounted to allow the page to be opened for review without disassembling the jacket and refolded without damage when the volume is shelved. 纸张长度应不小于10英寸[ 25.4cm] ，不超过12英寸[ 30.48cm]。然而,偶尔可能需要使用单独比标准纸张尺寸更大的页面来展示平面图,合成图,配方,或者生产指令。这些页面应该折叠嵌放以便打开检阅时不需要拆开护封，且在卷册存放时可再折叠而不会损坏。 IV.D.4. IV.D.4. The agencys system for filing DMFs provides for assembly on the left side of the page. The 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 submitter should punch holes 8 1/2 inches apart in each page. See the page measurements shown in the following figure: 代理的药品主文件归档系统提供在页面左侧装订。左边距应不少于3/4英寸[