30B型高效万能粉碎机的清洁验证方案（模板）.doc

验证方案目录 1. 引言····································································2 1.1 概述···································································2 1.2 验证目的·······························································2 1.3 验证人员及其职责·······················································2 1.4 验证周期·······························································2 1.5 验证进度安排···························································2 2. 清洁验证前的准备工作····················································3 2.1 验证所需文件···························································3 2.2 人员培训文件的检查·····················································3 3. 执行的清洁规程··························································3 4. 最难清洁部位的确定······················································3 5. 清洗验证标记产品的选择和可接受的残留限度································3 5.1 清洗验证标记产品的选择·················································3 5.2 产品信息·······························································4 5.3 可接受的残留限度·······················································4 6. 取样····································································5 6.1 取样点的确认···························································5 6.2 取样方法·······························································5 6.3 样品传递和储存·························································5 6.4 取样方法的验证·························································5 7. 检验方法验证····························································6 8. 清洁验证实施····························································7 9. 清洁有效期的确定························································7 10. 偏差的处理·····························································7 11. 评价与分析·····························································8 1. 引言 1.1 概述： 30B型高效万能粉碎机是***车间固体物料的粉碎设备，位于D级洁净区内的粉碎、过筛间内。 30B型高效万能粉碎机由底座、机壳、主轴、活动盘、固定盘、筛网、料斗和控制器组成，物料与活动盘、固定盘、筛网、料斗表面直接接触。 1.2 验证目的： 通过试验结果证明所制定的30B型高效万能粉碎机清洁规程能够清除活动盘、固定盘、筛网、料斗表面上的活性药物残留，使设备的清洗效果达到洁净要求，避免产品被残留物料和微生物污染。 1.3 验证人员及其职责：