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关于使用RO制备注射水的问答，这个是定稿，附件三个，一个是EMA官方原文，一个是与草稿的追踪对照中英文版，一个是终稿中英文版，可下载参考。
原文链接： 1 August 2017 GMP/GDP Inspectors Working Group Questions and answers onproduction of water for injections by non-distillation methods – reverse osmosisand biofilms and control strategies 非蒸馏方法制备注射用水问答---反渗透和生物膜及控制策略 Final 最终版 | Adopted by GMP/GDP IWG | | | GMP/GDP IWG采纳 | | | Start of public consultation | | | 开始公开征求意见 | | | End of consultation (deadline for comments) | | | 征求意见截止（截止日期） | |
This set of question and answers is intendedto provide preliminary guidance until such time the on-going revision of annexI of the GMP guide is complete. 此系列问答的目的是在GMP指南附录I完成持续修订之前提供初步的指南。 | keywords | Water for injections, reverse osmosis, biofilms, control strategies | | 关键词 | |
Introduction 前言 Following discussions over the last 2-3 years aroundthe revision of the European Pharmacopoeia (Ph. Eur.) Water for Injections (WFI)monograph (0169), the Water Working Party concluded that there was evidence tosupport a revision of the monograph, which proposes to take account of currentmanufacturing practices using methods other than distillation for producingwater of injectable quality. 在经过2-3年对EP注射用水（WFI）各论（0169）的讨论之后，药用水工作组得出结论认为有证据来支持对各论进行修订，提议考虑目前的生产做法，使用不同于蒸馏的方法来制备注射可用质量的水。 The Ph.Eur. monograph (Monograph 169) was revised toinclude, in addition to distillation, reverse osmosis (RO) coupled withsuitable techniques, for the production of WFI. EP各论（169）已进行了修订，包括除蒸馏以外的反渗透（RO）方法配置适当的技术用于制备WFI。 WFI monograph 169 states: WFI各论169说： Production 制备 Water for injections in bulk is obtained from waterthat complies with the regulations on water intended for human consumption laiddown by the competent authority or from purified water. 散装注射用水是从符合国家机构设定的饮用水规定的水源或从纯化水制备的。 It is produced either: 制备方法可以是： l by distillation in anapparatus of which the parts in contact with the water are of neutral glass,quartz or a suitable metal and which is fitted with an effective device toprevent the entrainment of droplets; or l 通过在一套设备中蒸馏来制备，该设备与水接触的部件应该是中性的玻璃、石英或适合的金属，安装了有效的装置来防止液滴夹带，或者 l by a purification process thatis equivalent to distillation. Reverse osmosis, which may be single-pass ordouble-pass, coupled with other appropriate techniques such aselectro-deionisation, ultrafiltration or nanofiltration, is suitable. Notice isgiven to the supervisory authority of the manufacturer before implementation. l 通过一个等同于蒸馏的纯化工艺来制备。反渗透就是适合的，它可是以一级或两级，配置适当的其它技术例如电除盐（EDI）、超滤或纳滤。生产商在实施之前要知会监管机构。 For all methods of production, correct operationmonitoring and maintenance of the system are essential. In order to ensure theappropriate quality of the water, validated procedures, in-process monitoringof the electrical conductivity, and regular monitoring of total organic carbonand microbial contamination are applied. 对于所有的制备方法，对系统进行正确的操作监测和维护是很重要的。为了保证制备的水具有恰当的质量，需要应用验证过的程序、电导中控监测和日常总有机碳监测和微生物污染监测。 The first portion of water obtained when the systembegins to function is discarded. 当系统刚开机时所制备的水应该弃去。 Water for injections in bulk is stored and distributedin conditions designed to prevent growth of micro-organisms and to avoid anyother contamination. 散装注射用水存贮和分送条件设计应防止微生物滋长，避免任何其它污染。 The purpose of these Questions and Answers is toprovide clarification and guidance in relation to the use of reverse osmosis inthe manufacture of Water for Injection (Part I) and also to provide moredetailed guidance on the control of Biofilms (Part II). 这些问答的目的是提供使用反渗透法制备注射水相关的澄清和指南（第一部分），同时也提供关于生物膜方面更详细的指南（第二部分）。
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