摘要
Abstract
The quality management system for pharmaceutical inspection plays a crucial role in ensuring that inspection activities are standardized,professional,and consistent.It simultaneously promotes the continuous development of pharmaceutical inspectorates,can effectively reduce discrepancies among different inspectorates,and provides essential support for international mutual recognition of inspections.Based on the theory of total quality management,this study systematically reviewed the requirements of relevant domestic and international regulations and guidelines pertaining to pharmaceutical inspection and quality management.Integrating insights gained from practical experience and the latest research findings in pharmaceutical inspection,it explored and constructed a comprehensive quality management system framework for pharmaceutical inspectorates.This framework is centered on pharmaceutical inspection regula-tions and guidelines,ensuring all inspection activities are conducted under unified normative guidance.It utilizes the PDCA cycle as its core operational mechanism,achieving continuous quality improvement through iterative cycles of planning,doing,checking and acting.The framework is supported by two key pillars:pharmaceutical inspection standards and procedures,and a team of professional pharmaceutical inspectors.These pillars respectively solidify the system's foundation from the dimensions of standardized institutional norms and human resource assurance.Furthermore,the framework is underpinned by fundamental quality management principles and modern scientific management methods,which together form its theoretical foundation,creating a hierarchical,well-structured,and coherent organic whole.The study further analyzed the specific connotations and implementation essentials of each quality management element within the context of the pharmaceutical inspection field.This research aims to provide theoretical foundation and practical guid-ance for pharmaceutical inspectorates in the process of establishing,implementing,evaluating,and continually improving their own quality management systems.关键词
药品检查/质量管理/管理要素/检查国际化/检查机构Key words
Drug inspection/Quality management/Management elements/Inspection internationalization/Inspectorates分类
医药卫生
