胶囊车间设备清洁再验证方案

胶囊车间设备清洁再验证方案及报告目 录 TOC \o "1-3" \h \z \u HYPERLINK \l "_Toc372271834" 1.验证人员及职责 PAGEREF _Toc372

胶囊车间设备清洁再验证方案及报告 目录 1.验证人员及职责 .......................................................... 3 2.目的 .................................................................... 3 3.周期 .................................................................... 3 4.相关的 SOP .............................................................. 3 5.设备 .................................................................... 4 6.测试方法 ................................................................ 4 7.接受限度 ................................................................ 5 8.风险分析 ................................................................ 5 9.抽样计划 ................................................................ 6 10.对不符合接受限度的测试结果所采取的措施 ................................ 10 11.再验证 ................................................................ 10 12.清洁验证过程记录 ...................................................... 10 附件1: 风险分析表: .................................................... 11 附件2: 风险分析表: .................................................... 12 附件3: 风险分析表: .................................................... 13 附件4: 风险分析表: .................................................... 14 附件5: 风险分析表: .................................................... 15 附件6: 风险分析表: .................................................... 16 附件7: 风险分析表: .................................................... 17 附件8: 风险分析表: .................................................... 18 附件9: 风险分析表: .................................................... 19 附件10: 风险分析表: ................................................... 20 附件11：目检和活性成分取样表 ............................................. 21 附件12：目检和微生物取样表 ............................................... 31 附件13：活性成分分析结果 ................................................. 41 附件14：微生物检查分析结果 ............................................... 51 附件15： 取样回收率试验 .................................................. 61 附件16：棉签特性研究 ..................................................... 63 附件17：清洁验证棉签取样 ................................................. 64 附件18：接受限度计算 ..................................................... 75 13.验证结果汇总表 ........................................................ 78 14.验证报告 .............................................................. 79