WHO现场主文件编写指南.docxVIP

? World Health Organization WHO Technical Report Series, No.961, 2011 1 基于制药检查会议对药品生产商编写现场主文件的注释 Based on the Explanatory notes for pharmaceutical manufacturers on the preparation of a site master file of the Pharmaceutical Inspection Convention. 附件14 Annex 14 WHO现场主文件编写指南1 WHO guidelines for drafting a site master file1 介绍Introduction 2. 目的Purpose 3. 范围Scope 4. 现场主文件的内容Content of site master file 附件 Appendix 现场主文件的内容 Content of a site master file 介绍Introduction 现场主文件是由药品制药商编写的，应当包含下列具体的信息：生产厂区的质量管理方针及活动、在指定的生产厂区实行的对药品生产操作的生产和/或质量控制以及在与其相邻的建筑物内所进行的任何紧密的完整的操作。如果只有一部分药品生产操作在此厂区内进行，那么在现场主文件中只需要描述这些操作，例如分析、包装等。 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. 当提交给监管机构时，现场主文件中应当包含对常规监督、有效计划及进行GMP检查有用的、关于制造商与GMP相关的活动的清晰信息。 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. 现场主文件中应当包含足够的信息，但加上附件尽量不要超过25～30页。用简单的计划、轮廓图或示意图来替代叙述性的文字是更可取的。当用A4纸张打印出时，现场主文件及其附件应当是可读的。 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. 现场主文件应是制造商质量管理体系文件的一部分，且应持续更新。现场主文件应有版本号、生效期和必须对其进行审核的日期。应当定期对现场主文件进行回顾以保证其包含了最新的信息和代表了当前所进行的活动。每个附件可以有单独的生效期，以便进行独立的更新。 The SMF should be a part of documentation belonging t