安徽宏业药业有限公司验证方案(初案)名称:天麻素注射液(2ml:0.2g)工艺验证方案部门职务签字日期验证方案起草人验证方案审核人验证方案批准人目录1.验证小组成员及职责···································32.产品概述·············································43.验证目的·············································44.验证范围·············································45.小容量注射剂车间天麻素注射液验证的培训··············46.验证时间和安排·······································57.工艺描述··············································58.验证前确认及准备·····································79.验证内容·············································1210.生产线环境检测······································3511.成品检验············································4312.持续稳定性考察······································4413.再验证周期··········································4414.结果分析与评价······································4415.验证结果············································4516.验证合格证书········································461.验证小组的成员及职责姓名部门资质职责2.产品概述天麻素注射液为中枢神经系统用药,本品为无色的澄明的液体;用于神经衰弱、神经衰弱综合症及血管神经性头痛症等,亦可用于脑外伤性综合症、眩晕症如美尼尔病、药性晕眩、外伤性晕眩、空发行耳聋、前疾神经元炎、推基底动脉供血不足等。该产品本次验证按天麻素注射液工艺规程,组织连续生产3批产品,规格为2ml:0.2mg;批量为40万ml,使用的主要设备通过验证,按验证方案进行取样,按国家的质量标准进行检验,并收集分析数据,验证完毕后,根据验证进程及检验结果,对配制(包括除菌过滤)、灌封、检漏等主要生产工序的相关参数进行确认,进一步完善生产工艺规程。3.验证的目的按照现有的生产设备和生产条件及批准的生产工艺连续三个批次的工艺验证,通过验证证明现有的生产设备和生产环境能够生产初出始终如一的质量稳定的产品。4.验证范围本次验证适用于小容量注射剂车间天麻素注射液(2ml:0.2mg)工艺验证,此次验证对天麻素注射液连续三个批次进行生产,并按取样计划进行取样、监测,按经验证的质量标准、分析方法进行测定。验证完毕,根据实际情况对生产操作规程相关参数进行确认和必要的调整。5.小容量注射剂车间天麻素注射液验证的培训必须参加的人员:待定培训时间:2013年09月08日至2013年09月10日期间必须培训完以上所有的人员。6.验证时间安排阶段特定批号时间安排第一批生产从2013年____月____日到2013年____月____日第二批生产从2013年____月____日到2013年____月____日第三批生产从2013年____月____日到2013年____月____日批号项目存放地点·批生产和检验记录资料室批生产和检验记录资料室批生产和检验记录资料室检查人:检查日期:复核人:复核日期:7.工艺描述7.1天麻素注射液原辅料处方、供应商及存储条件。(批量:40万ml)物料名称物料编号用量标准供应商存储条件天麻素《中国药典》2010版遮光,密封保存注射用水《中国药典》2010版密封保存活性炭《中国药典》2010版密封保存7.2小容量注射剂生产线工艺技...