1例BHK21工作细胞库升级为主细胞库的变更管理  

Change Control for Upgrading a BHK21 Working Cell Bank to a Master Cell Bank

作　　者：王红[1] 许敬敏[1] 罗珊[1] 吕冰凌[1] 杨锣[1] 彭维[1] 潘海龙[1] 

机构地区：[1]成都生物制品研究所有限责任公司,成都610023

出　　处：《预防医学情报杂志》2017年第3期201-204,共4页Journal of Preventive Medicine Information

基　　金：国家科技重大专项重大新药创制乙脑疫苗(2013ZX09402302-231)

摘　　要：目的执行变更控制管理程序规定,将数量少的BHK21工作细胞库升级为主细胞库,将主细胞库传代扩增成新的、数量较多的工作细胞即建立新的工作细胞库。方法菌毒种细胞管理部门质量检定室(QC)提出变更申请,质量营运部(QCM)召集质量符合性讨论会(QCF)对变更申请进行评估,将该变更分类确认为主要变更,制定变更实施计划、审核、批准,QC按照评估意见逐步实施并形成完善记录,QCF对变更实施结果进行评估,并决定同意变更有效并关闭。结果按照变更控制流程逐步完成各项计划步骤,根据《中国药典》(2010年版三部)检定用细胞的规定要求,对现用BHK21工作细胞库及新建工作细胞库施行细胞鉴别试验、无菌检查、支原体检查、外源病毒污染检查以及病毒敏感性检查,所有项目检定结果符合规定,QC签发检定报告,质量保证部(QA)审核签发合格报告。结论此例BHK21工作细胞库升级为主细胞的变更行动已完成,变更实施达到QCF变更申请评估要求,现用BHK21工作细胞库可升级为主细胞库,新建BHK21工作细胞库可用于乙脑减毒活疫苗(乙脑疫苗)和乙脑病毒SA14-14-2减毒株即乙脑疫苗生产用毒种的质量检定。Objective According to the change control procedure, to upgrade a BHK21 cell working seed bank with a smaller quantity of cells to a master seed bank, and propagate the master cell bank to generate a new working cell bank with a larger quantity of cells, establishing a new working cell bank. Methods QC, the con- trol department for bacterial, virus and cell seeds, submitted an application for the change. QCF defined this change as a major change after evaluating the change application. The implementation plan for this change was drafted, reviewed and approved. QC implemented the change according to the approved plan step by step and made the relevant records. QCF made an assessment of the change implementation result, and agreed on closing change. Results Following change control procedure, each planned activity was conducted stage by stage, fol- lowed by the cell identity test, sterility test, test for mycoplasma, test for adventitious viruses and virus sensitiv- ity on the current BHK21 working cell bank and the new working cell bank according to the requirements for cells for use in quality control in Chinese Pharmacopoeia 2010 （Volume Ⅲ）. All test results complied with related requirement. QC issued the certificate of analysis and QA issued the release certificate for cell bank. Conclusion The change activities for upgrading BHK21 working cell bank to master cell bank have been finished, the imple- mentation meets change assessment requirements proposed by QCF. The current BHK21 working cell bank can be upgraded as a master cell bank. The established BHK21 cell bank can be used for quality control tests on Japanese Encephalitis （JE） live vaccine and JE SA14 -14 - 2 attenuated strain （virus strain for JE live vaccine production）.

关 键 词：BHK21 工作细胞库 主细胞库 变更管理 

分 类 号：R329.24[医药卫生—人体解剖和组织胚胎学]