食品药品质量控制实验室仪器设备管理技术规范的比较

目的通过比较我国现行的食品药品质量控制实验室仪器设备管理的技术文件，来构建实验室仪器设备性能管理的理论基础，并应用于仪器设备性能管理的实践。方法比较资质认定评审准则（CMA）、与ISO／IEC 17025：2005《检测和校准实验室能力通用要求》对应的实验室认可评审准则（CNAS）及WHO《药品质量控制实验室良好操作规范》（GPCL）三种技术文件中仪器设备的要求，结合药品检测质量控制实验室的实践，探讨仪器设备性能管理的途径结果与结论CMA、CNAS和GPCL对仪器设备管理要求基本相同，GPCL要求更细致和严格。在实践中，符合ISO／IEC 17025质量管理规范的药品质量控制实验室，应适当地纳入GPCL中仪器设备性能鉴定的要求。

Comparison of Equipment and Instruments Management Technical Specification in Food and Pharmaceutical Quality Control Laboratories

Objective To compare the in Food and Pharmaceutical Quality Control performance requirements were compared current technical documents in equipment and instrument management Laboratories in China and create our own criteria. Methods Equipment among CMA, the international standard ISO/IEC 17025： 2005 ＂General requirements for the competence of testing and calibration laboratories＂ and the World Health Organization （WHO） ＂WHO good practices for pharmaceutical quality control laboratories＂ （GPCL）. Results and Conclusions The requirements of equipment and Instrument management are basically the same among CMA, CMAS and GPCL; however, equipment management in GPCL is the strictest in these three criteria; Food and Pharmaceutical Quality Control Laboratories that usually build QMS according to ISO/IEC 17025 should include the equipment performance testing required by GPCL.