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 ····················
