摘要
目的为药品检验实验室做好质量管理体系的文件化提供参考。方法分析了药品检验实验室质量管理体系文件化的目的和意义,介绍了文件的定义、形式和结构,阐述了如何编制、使用、控制体系文件,提出了完善体系文件的途径,并对规范管理检验方法这一类文件提出了可供参考的方案。结果与结论药品检验实验室应针对管理体系内的各个要素、各项活动编制既符合外部规定和要求,又适应本单位特点且能行之有效的体系文件。
Objective To provid a reference for the documentation of quality management system in pharmaceutical testing laboratories.Methods The purpose and significance of documented laboratory quality management system was briefly analyzed;the definition,form and structure of documents were introduced.The methods to edit,use,control and improve system documents were described;moreover,a proposal of how to standardize the documentation of test methods was brought forward.Results and Conclusion The pharmaceutical testing laboratories should establish documentation system to manage various elements and activities in the management system,which should not only comply with the external requirements but also be suitable and effective for the laboratories use.
出处
《中国药事》
CAS
2012年第12期1326-1329,共4页
Chinese Pharmaceutical Affairs
关键词
药品检验
实验室
质量管理
体系
文件
pharmaceutical testing
laboratories
quality management
system
documentation
作者简介
作者简介：杨美成，主任药师，主要从事质量管理和药物分析工作；Tel：（021）50798211；E—mail：yangmeicheng@vip．sina．com.
通讯作者：张河战，Tel：（010）67095785；E-mail：zhanghz@nicpbp．org．cn
