摘要
档案的建立和管理在药物非临床安全性评价和科学研究中都起到非常重要的作用。我们通过查阅文献发现,关于GLP机构档案管理的文献综述极少,涉及到将它与科研档案管理作系统全面的比较的文章是没有的。现从资料档案保存机构的硬件设施、档案管理规范和应注意的问题3个方面详细介绍了资料档案管理的相关规定和经验,并将GLP档案管理规范与科研档案管理规范作比较,我们根据国家档案局发布的《科学技术研究档案管理暂行规定》和7年GLP档案管理经验以及多次国家食品药品监督管理局(SFDA)认证现场检查的经历,总结出两者在功能实现、硬件设施、温湿度要求、档案防护、制定SOP、档案管理人员资质、各方人员职责、归档范围、归档形式、资料档案的接收与审查、归档时间、保管期限、借阅返还规定、资料的书写规范性、进出记录和电子文件的保存这16个方面的异同之处,突出GLP档案管理规范的特点和重点。通过这一深入全面的比较分析,得出GLP档案管理更加明确、具体、细致和可操作。
Archives establishment and management have played a very important role in non-clinical drug safety evaluation and any scientific research programe. Through literature review, we found that there is few literature review about GLP institutions archives management, when it comes to the systematic and comprehensive comparison on the establishment and management between GLP archives and scientific research archives, the relevant article is zero. This article comprehensively reviews relevant provisions and experience of archive management from 3 aspects of hardware facilities, archive practices and the problems we should pay attention to. Based on ＂Scientific and Technological Research Rrecords Management Interim Provisions＂ released by State Archives Administration, we compared the GLP archive practices and scientific research archive practices. Combined with author＇s seven years GLP archives management experience as well as multiple GLP certification on-site inspection of State Food and Drug Administration（SFDA）, summarized the similarities and differences between the two of them in the aspects of objectives, facilities, temperature and humidity requirements, file protection, setting up SOPs, archives management personnel qualification, responsibilities of the staff, archiving range, archiving form, receiving and reviewing data file, archiving time, retention period, borrowing and returning provisions, file writing normative, in and out record, preservation of electronic documents, further more, highlighted the characteristic and emphasis of GLP archives. Through this in-depth comprehensive comparative analysis, we arrival at a conclusion that the GLP archives management is more explicit, specific, detailed and operable. In order to narrow the gap between the developed countries and the international, to conform to the GLP development needs of the new era, we should discuss with colleagues how to further perfect the GLP archives management, to ensure the accuracy, clarity, reliability and traceability of the documents, and to improve the GLP organization＇s overall management level.
出处
《现代生物医学进展》
CAS
2014年第14期2763-2768,共6页
Progress in Modern Biomedicine
基金
国家"重大新药创制"科技重大专项(2011ZX09301-005)
上海市"科技创新行动计划"实验动物研究项目(11140901300
11140901302)
