八项质量管理原则在药品经营质量管理中的运用

Application of Eight Quality Management Principles in Drug Operation Quality Management

目的:探讨八项质量管理原则在药品经营质量管理中的运用,提高企业质量管理水平。方法:通过八项质量管理原则在药品经营活动中的具体实践,结合新版GSP的实施,运用质量管理原理对药品经营质量管理及实际操作进行指导。结果:找寻到我国现行药品GSP的理论渊源,增强企业学习、执行药品GSP及监管者的自觉性和自信心,提高企业管理者的质量意识,提升药品经营企业质量管理水平,尤其是"后GSP"时期质量管理水平的稳定和提高;为大型药品经营企业向国际水平靠拢,提供坚实的质量管理理论支撑。结论:八项质量管理原则贯穿于药品经营质量管理体系的始终,认真学习、理解和贯彻八项原则对于药品经营质量管理工作的开展及企业的发展具有促进作用。

Objective： To discuss the application of eight quaality mangement principles in drug operation quality manaqement, and improve the quality management of enterprises. Methds： Based on specific practice of eight quality management principles in drug operation activities,combined with the implementation of new GSP, the quality management principles were applied to guide drug operation quality management and practical operations.Results and Conclusion： By inquiring the theoretical origin of current Chinese GSP, the confidence and consciousness of enterprises and supervisors in learning and applying GSP were enhanced; the awareness of managers was promoted, the quality management of enterprises was improved. especially the stability and improvement of quality management in the ＂post GSP＂ period; and solid theoretical foundation was made for the stability and improvement of quality management on drug operation enterprise which aspire to reach international level.