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WHO第961号技术报告 附件14 工厂主文件准备指南（中英文），论坛有英文。
WHO第961号技术报告附件14 工厂主文件准备指南（中英文） World Health Organization WHO Technical Report Series, No.961, 2011 WHO第961号技术报告，附件14，工厂主文件准备指南 Annex 14 WHO guidelines for drafting a site master file[1]36 工厂主文件准备指南 1. Introduction 介绍 2. Purpose 目的 3. Scope 范围 4. Content of site master file 工厂主文件内容 Appendix 附件 Content of a site master file 工厂主文件内容
1. Introduction 介绍 1.1 The site master file (SMF) is prepared by the pharmaceutical manufacturer and should contain specific information about the quality management policies and activities of the site, the production and/or quality control of pharmaceutical manufacturing operations carried out at the named site and any closely integrated operations at adjacent and nearby buildings. If only part of a pharmaceutical operation is carried out on the site, an SMF need only describe those operations, e.g. analysis, packaging, etc. 现场主文件是由制药厂家编写，并包含以下信息：质量管理方针及现场活动、在对在指定现场进行生产或/和对在指定现场的制药生产操作进行的质量控制以及在临近及附近建筑内进行的一体化操作。如果仅有一部份制药操作在该现场进行，那么SMF仅需描叙该类操作即可，如：分析、包装、等。 1.2 When submitted to a regulatory authority, the SMF should provide clear information on the manufacturer’s good manufacturing practices ( GMP)-related activities that can be useful in general supervision and in the efficient planning and undertaking of GMP inspections. 提交至监管机构时，SMF需提供明确信息，说明厂家进行的有助于一般监管和GMP审查有效计划和应对的相关GMP活动 1.3 An SMF should contain adequate information but, as far as possible, not exceed 25–30 pages plus appendices. Simple plans, outline drawings or schematic layouts are preferred instead of narratives. The SMF, including appendices, should be readable when printed on A4 paper sheets. SMF应包含足够的信息，但是加上附件不得超过25-30页。相较于详述，简单性计划、简略的原理图布局图为首选。SMF，包括附件，用A4纸打印出来应当可读。 1.4 The SMF should be a part of documentation belonging to the quality management system of the manufacturer and kept updated accordingly. The SMF should have an edition number, the date it becomes effective and the date by which it has to be reviewed. It should be subject to regul | 
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发表于 2013-12-4 12:53:09
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