02、验证方案--xxx冻干制剂工艺验证

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1、验证方案方案编号：××××××冻干制剂工艺验证起草：签名日期审核：签名日期批准：签名日期验证方案方案编号：×××目录：1.介绍Introduction...............................................................................42.目的Objective....................................................................................43.职责Responsibility..

2、.........................................................................54.描述Description................................................................................64.1原辅料清单Listofrawmaterials..........................................64.2储存条件Storageconditionofmaterials

3、............................64.3工艺流程图Flowchartofproduction...................................74.4其他要求Specialinstruction.................................................84.5生产流程描述Descriptionofproductionprocess.............95.接受标准Acceptancecriteria...........................

4、...............................136.偏差处理HandlingofDeviation...................................................147.验证执行Qualification...................................................................157.1批生产记录Batchproductionrecord.................................157.2批检验记录Ba

5、tchanalyticalrecord....................................157.3关键参数测试Criticalattributetest...................................157.4SOP清单SOPlist.................................................................177.5培训Training......................................................

6、....................198.验证总结PQsummary....................................................................219.参考文件Reference...........................................................................2110.缩写Abbreviation.........................................................

7、..................2111.报告Reporting..................................................................................22验证方案方案编号：×××附录1.批生产记录2.批检验记录3.总结清单4.偏差记录4.1偏差调查5.签名清单6.培训清单7.测试仪器清单8.关键参数测试8.1过滤前产品溶液含量均匀度8.2灌装前废弃溶液量8.3储存后溶液含量均匀度8.4灌装中间检查8.5冻干均匀度测试9.检验方法请单起草人验证方案方案编号：××

8、×1.介绍×××公司计划在一车间冻干粉针生产线生产×××冻干产品，产品的批量是×××瓶，在本工艺验证中将验证三批产品。一车间的冻干粉针生产线包括配液罐、灌装线、冻干机、洗瓶机、热