目 录
一．药品生产质量管理规范（GMP生产）的意义·························2
二．GMP药品生产企业存在的主要问题及原因分析························2
企业的关键人员GMP意识不强，员工培训工作不到位···············2
厂房设施设备没有及时得到维护与保养····························3
生产管理不严格，对关键岗位没有按要求达标······················3
企业的质量管理部门对生产过程的放松····························4
不重视自检工作················································4
文件制定与实际不符合··········································4
三．解决问题的对策··················································4
（一）重视员工的GMP文件培训·······································4
（二）按时对设备进行全面维修与维护··································4
（三）加强GMP管理················································5
（四）质管部门应加紧对生产过程的监控·······························5
（五）重视自检·····················································5
（六）制定合理的适合本企业的文件···································5
参考文献··························································6
引言：近年来，药害事件时有发生，比较严重的有2006年以来的“齐二药”事件：这是一起不法商人销售假冒药用辅料，齐二药采购和质量检验人员严重违规操作，使假冒药用辅料制成假药投放市场进而致人死亡的恶性案件。“欣弗”事件：安徽华源生物药业有限公司2006年6月到7月生产的克林霉素磷酸酯葡萄糖注射液未按批准的工艺参数灭菌，降低灭菌温度，缩短灭菌时间，增加灭菌柜装载量，影响了灭菌效果，经国家药品生物制品检定所对相关样品进行检验后表明，无菌检查和热原检查不符合相应的规定要求。广东佰易药业生产的丙种白蛋白携丙肝病毒事件，修正药业发生的“毒胶囊”事件等，这些药害的发生都与药
