对2010版GMP质量控制实验室检查方法的探讨

Discuss on the laboratory examination for quality control of GMP 2010

目的对省内药品生产企业2010版GMP质量控制实验室检查中存在的缺陷进行分析,为GMP检查提供参考。方法从实验室人员、仪器、试剂、原始数据和检验环境等影响因素出发,对所存在缺陷进行分析。结果与结论深入理解GMP理念,把握好检查方向,把检查工作做扎实。

Objective To analyze the defects thar existed in the laboratory examination for quality control when the pharmaceutical enterprises carried out the GMP 2010,in order to guide the GMP inspections. Methods Defects were analyzed from laboratory personnel, instrument,reagent, initial data and tesr surroundings. Results and Conclusion To understand the philosophy of GMP,focus on the key point and make a solid job of inspection.