工艺步骤 主要设备 Process step Critical Equipment 贮存时间验证 100L不锈钢桶 Holding time study 批记录对应步骤 Reference After Step7d/9 in BF2340 05 进行3个月加速稳定性监测 Accelareted stability test of 3 months 符合稳定性可接受标准SOP-STS004 meet the specifications of SOP-STS004 留样产品可以释放 release the retained product 5.9.2 取样和测试计划Sampling and testing plan 中间体 Intermediate 取样时间 Sampling time 取样位臵Sampling position 取样量 化学Chem. 测试方法即可接受标准Test method / Acceptance criteria 加速稳定性 半成品 Accelareted stability Half finsihed product test 第0天、第15天、第30天分第0天、第30天、第60天、第0天、第1月、第2月、第别取样sampling on the 0, 15, 第90天分别取样sampling on 3月分别取样sampling on the 30 days the 0, 30,60,90 days 0, 1, 2, 3 months SMP-QMP014 微生物Micro. 物料上表面取 on the surface SMP-QMP051 盛装容器内物料中心位臵in the inner center 化学Chem. 微生物Micro. 微生物100g，每次均应取各自的备份样 Micro: 100mg, backup sample is needed 化学200g，每次均应取各自的备份样 Chem: 200 mg, backup sample is needed SOP-INS005 SOP-HPS005 QF0016 SOP-STS004 测试项目 Test Items 形状、含量测定、微生物限度性状、鉴别（甲苯咪唑、日落性状、崩解时限、有关物质、检查appearance, assay, 黄）、重量差异、崩解时限、含量测定、微生物限度检查micro. apperance, disintegration, 脆碎度、有关物质、含量测定、有机溶剂残留量、微生物impurity test, assay, micro. test 限度检查apperance,identification( Mebendazole,Sunset yellow), tablet weight variation, disintegration, friability, impurity test, assay, residual solvents, micro. test
6 验证中偏差/变更处理DEVIATION AND CHANGE HANDLING
验证过程中如果出现偏差和变更，应立即通知验证小组并对偏差和变更进行详细记录（QF1039验证偏差处理单，QF1040验证变更处理单），分析偏差产生的根本原因、进行影响分析并提出解决方法。所有偏差和变更得到有效处理后，并且已被质量认证部代表批准和关闭，验证方可进入下一步骤。原始的偏差处理单和变更处理单经过批准后必须附在最终的验证报告中。
If any deviation and change is issued during validation, it must be immediately informed to validation team and recored in the deviation handling form and/or change handling form (QF1039 and QF1040). The root cause, impact assement and CAPA should be givend after full investigation. The validation could be continued only after effective handling with approving by Q&C representative. The handling form should be attached to the final validation report.
7 培训TRAINING
验证草案起草人有责任在验证草案批准后对本次验证相关人员进行培训，该培训记录连同在验证中完成的其他相关培训记录一起附在最终的验证报告中。
The validation author is responsible for train the related person after receiving the approved protocol. All of he training records should be attached to the final validation report.