蒸汽消毒柜iq

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1、方案第2版蒸汽消毒柜系统安装确认方案（IQ）XXX药业有限公司XXX药业有限公司安装确认方案名称：蒸汽消毒柜系统方案号：PIQ013-2版本号：第2版共19页第1页生效日期：描述：蒸汽消毒柜系统安装确认方案编写人：日期：审阅人：日期:审阅人：日期:审阅人：日期:审阅人：日期:批准人：日期:QA经理最初方案批准：页总经理日期：副总经理日期：质量保证部经理日期：生产技术部经理日期：机械动力部经理日期：XXX药业有限公司安装确认方案名称：蒸汽消毒柜系统方案号：PIQ013-2版本号：第2版共19页第2页目录名称页数1．目的····································

2、······························32．范围··································································33．方案说明······························································34．系统描述······························································45．供应商提供的技术文件·············································

3、·····56．购买定单和发票························································67．工程图纸······························································78．备用零件······························································81．与物品接触的材料······················································92．公用工程要求··············

4、············································103．报告··································································114．实地确认······························································12A．设备·······························································12B．管道····································

5、···························14C．仪表/装置··························································155．偏差表································································176．总结··································································187．最终方案审阅与批准···············································

6、·····19XXX药业有限公司安装确认方案名称：蒸汽消毒柜系统方案号：PIQ013-2版本号：第2版共19页第3页1．目的本方案的目的是用于验证蒸汽消毒柜是根据相应的说明书、图纸安装的。2．范围本方案的范围提供了检查本系统的概要。本IQ应表明：A．已安装的设备符合工程设计图纸和设备一览表的规格。B．本系统/设备是根据设计图纸和生产厂家设备说明书安装的。C．备品备件清单完备且准确，并且所有的操作、预防性维护等手册完备。D．所有的安装测试报告完备并保存于设备历史档案中。E．本系统符合现行的GMP要求。F．没有事先批准或有文件记录的变更管理程序不得进行任何整改。G．所有与安全有关的内容已形成

7、文件。3．方案说明A．尽可能详细地填写本方案中的所有表格。用墨水笔填写。完成表格的人员应在底部“核实人”一栏签上姓名和日期。如果由一个以上的人填写，那么每一个人都应签上姓名和日期。每一表格都应由一个高层验证小组人员进行审阅和签字。B．方案执行时可能会发现偏差。可能是由于与说明书、工程图纸等不符而发生偏差。一旦这种情况发生，应将一份“异常情况报告”送交验证领导小组进行处理。C．验证小组在验证结束后应做作出一份最终总结报告，并由华北XX