摘要
目的:为完善制药企业《药品生产质量管理规范》(GMP)文件管理提供参考。方法:介绍笔者提出的GMP文件生命周期管理模型,依据该模型开展调研与实践,分析制药企业GMP文件生命周期管理中存在的问题,并提出相应措施。结果:当前制药企业的GMP文件存在起草缺乏系统性、完整性、可操作性及扩展性,文件审核形式化,文件执行人员培训效果不佳,文件执行不到位和文件处置不当等问题。应依据GMP文件生命周期管理模型,采取顶层设计GMP文件、明确职责和加强文件审批、强化培训管理和提升培训效果、完善奖惩机制和加强文件执行力度、科学存放文件、开展文件的变更控制等措施。结论:建立一套系统、科学、实用的文件管理系统并有效开展GMP文件生命周期管理,对提升制药企业的质量管理水平和促进新版GMP的有效实施具有举足轻重的作用。
OBJECTIVE ： To provide reference for the improvement of Good Manufacturing Practice （GMP） document management of pharmaceutical enterprises. METHODS： Introducing GMP document lifecycle management model, according to research and practice of the model, the problems about GMP document lifecycle management of the enterprises were analyzed to propose appropriate measures. RESULTS ： The problems about GMP document of pharmaceutical enterprises included absence of systematic, integrate, operable and scalable drafting, formalized documentation review, unsatisfactory staff training, inadequate operation and unsuitable disposal, etc. According to GMP document lifecycle management model, it was suggested to design the GMP documents on the top level; define the responsibilities and reinforce the documents approval; strengthen training and management and improve the effects of training; improve the mechanism of rewards and punishments, and enforce the implementation of documents; store documents scientifically and carry out document changes control. CONCLUSIONS： It has very important function to enhance the quality of enterprise management level and promote the effective implementation of new GMP by establishing a systematic, scientific and practical document management system and implementing the GMP document lifecycle management effectively.
出处
《中国药房》
CAS
CSCD
2014年第5期391-394,共4页
China Pharmacy
基金
浙江省高校优秀青年教师资助计划项目(No.KZJY2011004)
浙江省高校青年骨干教师访问工程师项目
关键词
制药企业
药品生产质量管理规范
文件
生命周期
管理
Pharmaceutical enterprises
Good Manufacturing Practice
Document
Lifecycle
Management
