药品检验机构实验室管理体系文件系统的架构及编制要点

The structure and establishment of the management system document of the drug control agency

为药品检验机构实验室管理体系文件系统的建立和文件编制提供参考,本研究参照国内外的实验室管理规范性文件,结合药品检验机构实验室实际工作的特点,分析药检实验室管理体系文件的架构及内容要点。结果显示,药品检验机构实验室应根据自身规模、组织机构设置等方面的特点设计策划其管理体系文件系统的架构和层次,应保证文件具备系统性强、覆盖全面、内容适宜可操作性强、能充分发挥见证性等方面的特点。可见,实验室的管理体系是通过管理体系文件系统来实现的,建立并完善管理体系文件是为了进一步理顺关系,明确职责与权限,协调各部门之间的关系,使各项活动能够顺利、有效地实施。

To provide reference for the establishment and composing of the document system of the management sys- tem in drug quality control laboratories, this study based on the characteristics of drug quality control business of the drug testing laboratories, considering the related requirements from relevant guidelines for quality management of test- ing laboratories, the structure of the document system and the requirements for the composing of the documents are an- alyzed. Results show that, the drug control agency＇s management document system should be structured concerning its scale and organization, and the document system should be well organized and comprehensive. The content of the docu- ment should be appropriate, operable, and evidential. It prompts that, the laboratory management system is achieved through the management document system. The establishing and maintaining of the management document system is to further rationalize the management line, clarify the responsibility and authority, so that the activities can be implement- ed smoothly and effectively.