欧洲官方药品质控实验室分析仪器验证介绍

目的 介绍欧洲官方药品质控实验室仪器管理和仪器验证经验.方法 详细阐述了欧洲官方药品质控实验室仪器验证指导原则主文件和附录文件,并以常规的液相色谱仪为例,探讨了仪器验证的四个主要步骤.结果与结论 介绍欧洲药品质控实验室对药品检测仪器的管理和仪器验证操作经验,结合我国药品检测实验室情况,为我国药品质控实验室仪器验证与国际接轨提供参考.

Introduction of Analytical Instrument Qualification of OMCLs

Objective To introduce the experience of management and equipment qualification from the European Directorate for the Quality Control of Medicines and Health Care. Methods Official Medicines Control Laboratory （OMCL） Guideline on qualification of laboratory equipment-the core document elaborated by the European Network of OMCLs was introduced in details. The application of OMCL Guideline on qualification of HPLC equipment （Annex 1） was taken as an example to explore the four steps of equipment qualification of OMCLs. Results and Conclusion Combining the equipment qualification experience from the European network of OMCL with the current situation of drug quality control laboratories in China, references were provided in this paper for improvement of the drug quality control laboratories and laboratory quality management in China.