001设清洁验证方案.docVIP

编 号：版本号： 设备清洁验证方案部门：验证机构编号：V-C-001起草： 日期：类别：验证方案设备清洁验证方案审核： 日期：颁次：批准： 日期：替代：生效日期：颁发部门：分发部门： 目 录 TOC \o 1-3 1. 概述 GOTOBUTTON _Toc499029311 PAGEREF _Toc499029311 21.1 设备特性描述 GOTOBUTTON _Toc499029312 PAGEREF _Toc499029312 21.2 使用本设备生产的产品 GOTOBUTTON _Toc499029313 PAGEREF _Toc499029313 22. 验证目的 GOTOBUTTON _Toc499029314 PAGEREF _Toc499029314 23. 职责 GOTOBUTTON _Toc499029315 PAGEREF _Toc499029315 33.1 验证委员会 GOTOBUTTON _Toc499029316 PAGEREF _Toc499029316 33.2 工程部 GOTOBUTTON _Toc499029317 PAGEREF _Toc499029317 33.3 质量部 GOTOBUTTON _Toc499029318 PAGEREF _Toc499029318 33.4 生产部 GOTOBUTTON _Toc499029319 PAGEREF _Toc499029319 34. 原理 GOTOBUTTON _Toc499029320 PAGEREF _Toc499029320 35. 验证内容 GOTOBUTTON _Toc499029321 PAGEREF _Toc499029321 45.1 验证的准备工作 GOTOBUTTON _Toc499029322 PAGEREF _Toc499029322 45.1.1 验证所需文件资料 GOTOBUTTON _Toc499029323 PAGEREF _Toc499029323 45.1.2 验证所需的试验条件 GOTOBUTTON _Toc499029324 PAGEREF _Toc499029324 45.2 参照检测对象的选择 GOTOBUTTON _Toc499029325 PAGEREF _Toc499029325 45.3 确定最差条件参数 GOTOBUTTON _Toc499029326 PAGEREF _Toc499029326 55.4 确定检验方法 GOTOBUTTON _Toc499029327 PAGEREF _Toc499029327 55.5 取样方法的确定 GOTOBUTTON _Toc499029328 PAGEREF _Toc499029328 55.5.1 化学验证取样 GOTOBUTTON _Toc499029329 PAGEREF _Toc499029329 55.5.2 微生物验证取样 GOTOBUTTON _Toc499029330 PAGEREF _Toc499029330 65.6 取样回收率试验 GOTOBUTTON _Toc499029331 PAGEREF _Toc499029331 65.7 确定残余物限量标准 GOTOBUTTON _Toc499029332 PAGEREF _Toc499029332 65.7.1 化学样品可接受标准 GOTOBUTTON _Toc499029333 PAGEREF _Toc499029333 65.7.2 微生物取样可接受标准 GOTOBUTTON _Toc499029334 PAGEREF _Toc499029334 75.8 取样计划 GOTOBUTTON _Toc499029335 PAGEREF _Toc499029335 75.8.1 取样点的确定 GOTOBUTTON _Toc499029336 PAGEREF _Toc499029336 75.8.2 验证次数 GOTOBUTTON _Toc499029337 PAGEREF _Toc499029337 75.9 验证实施 GOTOBUTTON _Toc499029338 PAGEREF _Toc499029338 75.10 拟订