GMP培训资料--质量管理体系介绍.ppt

压缩空气 当系统变更或维修时会对制备或分配的物料的质量有影响 根据测试结果，对验证过的状态有疑问 再验证周期如下： 供应物料的系统或供应的物料与产品有接触或供应物料的系统或供应的物料接触与产品接触的表面——每5年进行一次再验证 如果日常监测结果符合要求，年度数据回顾可用于再验证 其他供应和处理系统——无要求 * 纯化水系统 当技术变更对关键参数有影响 系统维修时对系统功能有影响可以说对水的质量有影响 使用的工艺或原料变更时对水的质量有影响 因有质量问题的出现或趋势对验证的状态表示怀疑 固定间隔：纯化水系统再验证周期为3年 生产设备 每3年至5年 实验室仪器、设备 周期性校准及仪器功能测试：每1～12月 湿热、干热灭菌锅：每年 其他仪器、设备：每5年 * 一期扩建项目投入使用前，对新的生产区走廊、办公室、初级包装间（CCE）及次级包装间（CCF）的运行验证（系统号： 2.094、 2.095、 2.096、 2.097 ） 在保持15rpm的情况下，将压片前的混合时间从15秒增至1分钟，即重复批量为60-250kg生产过程3个循环完成（系统号： 1.003 ） 实验室纯水系统更换反渗透柱，对其产水水质、回水水质及代表性使用点水质的验证。（系统号： 4.044 ） 容器清洗间1.1.10内新装自动门，将原房间分为两个区域（待清洁间1.1.10和已清洁间1.1.38），从而进行运行验证和再验证。（系统号： 2.082 ） * * First, let me give you a quick overview about how our operations at Bayer HealthCare are set into the framework of the Bayer family of subgroups and service companies.  Bayer Healthcare is one of three subgroups of Bayer! Bayer CropScience and Bayer MaterialScience being the other two. These are supported by three service companies which also offer service to external customers. Our Sales in 2005 have been 27.4 million Euro. Bayer has ~ 94.000 employees worldwide and is investing Euro 1.9 million in research. First, let me give you a quick overview about how our operations at Bayer HealthCare are set into the framework of the Bayer family of subgroups and service companies.  Bayer Healthcare is one of three subgroups of Bayer! Bayer CropScience and Bayer MaterialScience being the other two. These are supported by three service companies which also offer service to external customers. Our Sales in 2005 have been 27.4 million Euro. Bayer has ~ 94.000 employees worldwide and is investing Euro 1.9 million in research. First, let me give you a quick overview about how our operations at Bayer HealthCare are set into the framework of the Bayer family of subgroups and service companies.  Bayer Healthcare is one of three subgroups of Bayer! Bayer CropScience and Bayer MaterialScience being the other two. These are supported by three service c