药品检验机构实验室文件控制的研究

Laboratory Document Control in Pharmaceutical Inspection Institutions

目的为药检实验室开展系统化的文件控制工作提供参考。方法参照CNAS CL01:2006、WHO GPPQCL等国内外先进实验室认证认可准则和管理规范,结合药检实验室文件系统建立与文件管理工作的实践经验,针对药检实验室管理体系文件的整个生命周期,分析药检实验室文件控制中各个环节的控制要点及管理方法。结果实验室管理体系的运行是通过管理体系文件系统来实现的。结论只有对管理体系文件系统实施有效控制,确保体系文件的持续适宜和执行效果,才能保证实验室管理体系的平稳运行和机构的持续发展。

Objective To provide reference for the establishment of systematic document control in pharmaceutical inspec- tion laboratory. Method Referring to the advanced laboratory accreditation standards and management practices, such as CNAS CL01：2006, WHO GPPQCL, combining with the practical experiences from the establishment of document system in pharmaceu- tical inspection laboratory and the document management, the key points of document control and management methods were sys- tematically analyzed, covering the whole life circle of document in the management system. Result The management system in la- boratory was achieved through the implementation of the document management system. Conclusion The effective control of the document management system and ensuring continuing suitability and implementation of the system documentation can ensure the smoothly running of laboratory management system and sustainable development of institution.