FC系列重量检测机验证方案.doc

FC系列重量检测机验证方案 批准程序 职 位 姓 名 签 名 日 期 起草 QA 审阅 验证组长 生产部经理 工程部经理 制造总监 质量受权人 批准 QA  目录 1.概述······························································ 3 2.目的·························································· 3 3.职责···························································· 3 4.引用文件·································································· 3 5.部件关键性评估，关键部件风险评估······························································· 4 5.1评估依据···························································································································· 4 5.2关键部件识别方法及结果································································································ 6 5.3关键部件风险评估············································································································ 7 6.确认内容······························································································································· 9 6.1安装确认（IQ）················································································································ 9 6.2运行确认（OQ）·············································································································· 10 6.3性能确认（PQ）··············································································································· 10 附表FC系列重量检测机验证方案测试表 附表1 先决条件 附表2 仪器、仪表确认 附表3 安装确认 附表4 运行确认 附表5 性能确认 附表6 签到培训表 附表7 确认结果评价表 1 概述 FC230型皮带式称重机采用德国HBM传感器，配备先进的动态重量信号处理软件，丰富的软件、电子、机械选件，用于满足制药行业的在线称重要求。现将一台重量检测机用于激素外用药制剂车间外包生产线的称重。 ?? 设备名称 ?? FC230型皮带式称重机 设备编号 R107 设备型号 FC230型 生产厂家 上海波峰电子有限公司 安装位置 激素外用药制剂车间二楼手工包装间 2目的 ??通过验证活动，证明FC230型皮带式称重机在未来可能发生的种种情况下能够连续、稳定地满足生产需要，通过文字性的依据、试验数据等证明被验证的FC230型皮带式称重机符合要求，并能满足生产需要。 3职责 ?? 姓名 ?? 部门 职责 工程部 审核验证方案及报告，现场调试人员的调度。 生产部 审核验证方案报告，现场操作人员的调度及配合验证工作。 质保部 验证方案的起草、组织实施、汇总验证数据及完成验证报告。 质保部 验证方案及报告的审阅。 生产部 验证方案及报告的审阅。 质保部 验证方案及报告的审阅与批准，验证工作的协调与确认、验证资源的提供。 4参考标准 ?? 序号 ?? 名称 编号 1 《药品生产质量管理规范》2010版 -- 2 《药品生产验证指南》2