生产厂房设施验证方案VIP免费

题目XXXXXXXXXXXXXXXXXXXXXXXXX生产厂房设施验证方案编码YZ-CF-001-01执行部门生产部、质量保证部颁发部门颁发日期执行日期起草人审核人批准人起草日期审核日期批准日期目的：检查并确认我公司XXXXXXX粘合剂产业化项目（一期）车间厂房、设施符合GMP及生产工艺要求，文件符合GMP的管理要求。范围：XXXXXXXXX粘合剂产业化项目（一期）车间生产厂房设施责任人：生产部、质量保证部、质量检验部、生产车间目录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：..........................................................................................................................32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：.............................................................................................................65.1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.....................................................