初论药品质量控制实验室质量管理规范的基本框架

Basic Framework of Quality Management Criteria for Pharmaceutical Quality Control Laboratories

目的建立符合我国药品质量控制实验室实际又与世界卫生组织(WHO)要求相适应的质量管理规范,来指导、规范药检系统实验室质量管理体系建设。方法以国际标准ISO/IEC 17025:2005《检测和校准实验室能力通用要求》为基础,结合我国药检机构的质量管理现状,吸收WHO《药品质量控制实验室良好操作规范》(GPCL)的有关要求。结果与结论药品质量控制实验室质量管理规范的基本框架应分为质量管理、技术管理和实验室安全3个方面,包括13个管理要素、12个技术要素、1个安全要素,共同构成药品质量控制实验室质量管理体系。

Objective To set up quality management criteria for the pharmaceutical quality control laboratories in China, and to guide, standardize the quality management system construction of pharmaceutical laboratories. Methods The international standard ISO/ IEC 17025： 2005 ＂ General requirements for the competence of testing and calibration laboratories＂ was applied as the fundament, and the relevant requirements of the World Health Organization （WHO） ＂Good practice for pharmaceutical control laboratories＂ （GPCL） was taken up in combination with the current situation of quality management in domestic drug control institutes. Results and Conclusion The basic framework of quality management criteria for the pharmaceutical quality control laboratories should contain three aspects quality management, technique management and laboratory safety, including 13 management elements, 12 technical elements and one safety element which together form the quality management system of pharmaceutical quality control laboratories.