我国药品认证检查机构建立统一的质量管理体系的必要性分析

目的:探讨我国药品认证检查机构建立统一的质量管理体系的必要性。方法:分析我国药品认证检查机构质量管理当前存在的问题,从认证风险、自身建设、法规要求、国际互认等4个方面论述建立统一的质量管理体系的必要性。结果与结论:我国药品认证检查机构当前存在的问题有管理者质量理念和风险意识淡薄、质量管理存在薄弱环节、质量管理水平与医药经济发展形势不相适应等。建立统一的质量管理体系是降低药品认证风险、提高认证管理水平、增强法规依从性、促进药品检查国际互认的有效措施。

Analysis of the Necessity of Establishing Uniform Quality Management Systems in Pharmaceutical Certifi- cation and Examination Institution in China

OBJECTIVE： To discuss the necessity of establishing uniform quality management systems in pharmaceutical certifi- cation and examination institution in China. METHODS： The problems of current quality management were analyzed in pharmaceu- tical certification and examination institution. The necessity of quality management systems in pharmaceutical certification and exam- ination institution were introduced from the risk of pharmaceutical certification, the construction of pharmaceutical certification and examination institution, requirements of regulation and international mutual recognition. RESULTS ＆ CONCLUSIONS： The prob- lems of pharmaceutical certification and examination institution are bad quality conception and risk consciousness, the weakness of quality management and incompatibility of quality management with pharmacoeconomic development. Uniform quality management system is an effective tool in reducing risk of pharmaceutical certification, improving the level of pharmaceutical certification and management, increasing the ability of regulation complying and improving international mutual recognition.