药品生产过程中需要注意的问题及对策

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品生产企业在药品生产质量监管方面出现的漏洞有关，下面我就上述事件中所出现的问题进行分析和讨论，希望这样的事件不要再继续发生。