生产厂房设施验证方案编码：目录1概述........................................................................................................................................................31.1工厂描述......................................................................................................................................31.2生产区描述..................................................................................................................................31.3其他建筑描述：..........................................................................................................................31.4公用系统描述：..........................................................................................................................3颁发部门：生产技术部执行日期：年月日起草人审核人质量保证部审阅人批准人年月日年月日年月日年月日分发部门：变更记载：修订号批准日期执行日期年月日年月日生效日期：年月日变更原因及目的：2验证目的.................................................................................................................................................33验证的范围：.........................................................................................................................................44验证职责.................................................................................................................................................45验证的相关文件及验证依据：.............................................................................................................55.1验证的相关文件：......................................................................................................................65.2验证的依据：..............................................................................................................................66验证实施前提条件.................................................................................................................................67厂房设施质量风险评估.........................................................................................................................68验证时间安排.........................................................................................................................................79验证内容.................................................................................................................................................79.1厂房检查确认..............................................................................................................................79.2文件资料的确认：.....................................................................................................................89.3、仪器仪表的校准或检定检查确认：.......................................................................................910运行确认：...........................................................................................................................................910.1运行确认包含内容：................................................................................................................910.2设备确认..................................................................................................................................1010.3空调系统............................................................................
