中检院化学药品检定所人员岗位培训和资质授权的管理实践

Practice of Staff Training and Qualification in Quality Management System of NIFDC

目的在中国食品药品检定研究院化学药品检定所建立符合国际标准的实验室质量管理体系。方法按照世界卫生组织《药品质量控制实验室良好操作规范》(简称WHO GPPQCL)要求,结合实际情况,从岗位设置、人员培训、考核、岗位资质获得以及建立档案5个方面,系统介绍了人员管理的实践。结果与结论建立了符合WHO GPPQCL要求的质量管理体系,规范了技术人员的质量管理,提高了实验室质量管理的水平。

Objective To establish a laboratory quality management system which is in accordance with national standard requirements. Methods According to the World Health Organization ＂Good Practice for Pharmaceutical Quality Control Laboratories （WHO GPPQCL）, the practice of personnel management in NIFDC was introduced on five aspects of position description, staff training, assessment, position qualifications and archive construction. Results and Conclusion The laboratory quality management system was established which is in accordance with WHO GPPQCL. The personnel management and the laboratory quality management were standardized and improved.