方案编码：FA-SB-02-00分 类： 设备验证 型脉动真空灭菌器确认方案OOOOOOOO 药业有限公司 2024 年 06 月 验证方案文件名称型脉动真空灭菌器确认方案编码FA-SB-02-00页码第 2 页 共 40 页起草人： 日期：审核人： 日期：审核人： 日期：审核人： 日期：审核人： 日期：质量保证部审核人： 日期：批准人： 日期：生效日期：前版本无现版本第 01 版本次验证理由或依据本次验证内容目 录1、确认的目的 ·····················································42、验证小组的职责与分工 ···········································43、验证方案的培训 ·················································44、风险分析 ·······················································45、设计确认 ·······················································56、安装确认 ·······················································97、运行确认 ·······················································118、性能确认 ·······················································169、变更控制 ······················································1710、缺陷分析与评估 ···············································1711、验证分析评价及验证结果 ········································1712、再确认建议············· ··························1813、文件附件 ······················································191、确认目的 型脉动真空灭菌器是由山东新华医疗机械股份有限公司开发生产的高档...
