【作者】 李春霞；

【导师】 魏振平； 陈树生；

【作者基本信息】 天津大学 ， 制药工程， 2012， 硕士

【摘要】 2010年修订版《药品生产质量管理规范》发布以后,我们根据新版GMP进行自检,针对自检结果对清热解毒口服液生产线的配套系统、关键设备、人员培训和生产工艺进行相应升级改造和再验证,主要研究内容包括:对空调净化系统进行自检,分析存在问题并提出检修和改造方案,最后从系统安装、运行和性能三方面对改造后的系统进行验证,证明改造后系统能更好的运行、操作和维护,保证洁净区的空气环境符合GMP要求。对纯化水系统进行自检,针对出水管路乱、盲点多等缺陷提出管路改造方案,最后从系统安装、运行和性能三方面对改造后系统进行验证。验证表明,改造后的系统更适合纯化水生产、系统操作和维护保养,确认对整个循环系统未造成污染,各使用点的出水水质符合要求、供水正常。经过自检,对存在问题的关键设备进行改造、人员培训和再验证,包括对口服液压滤系统滤材的筛选与验证,口服液配液罐增加容量后的验证,筛选、优化内包装后口服液灌轧机的验证,压力蒸汽灭菌器的维修后验证和对操作人员培训等活动。验证结果表明我公司关键设备经改造、优化后满足工艺规范要求,有利于保证药品质量、降低成本和提高生产效率。在相关设备设施改造后对清热解毒口服液生产工艺进行优化和验证,通过对该产品各个工序、各个关键控制点的实验跟踪,结果表明利用升级改造后的设备和系统,按照优化后的生产工艺生产的口服液符合预定标准,且质量更稳定。更多还原

【Abstract】 Accoring to the newest edition G MP revised in 2010, we have self-inspected, upgraded and revalidated the related system s, critical equipments, personnel training and process use for Qingrejiedu Oral Li quid production. The m ain study work are shown as following:Studied on the potential pr oblem of air purifying system , and presented the optimized plan s econdly, and th en re validated the upgraded system including Installation Qualification, Operational Qualification and Perf ormance Qualification. Accroding to the revalidation, the upgraded system is m ore suitable for running, operation and maintanence, the purfied air in clean space can satisfy the requirement of GMP.Self-inspected the water purifying system and analysed the problem such as blind area and orderless exsiting in the old system, and the optimized plan have been presented secondly, and then revalidated the upgraded system including Installation Qualification, Operational Qualification and P erformance Qualification. Accroding to the revalidation, the upgrad ed system is more suitable for running, operation and maintanence, satified the requirem ents for production, to evey process continuously and stably. According to the problem found during self-inspection for the critical equipment, Upgraded the Filtrating Material, Mixing Po t, Bottle Filling & Sealing Instrum ent, Pressurized S teamy S terilization Instrum ent, m eanwhile training the personnel to suitable for their work, lastly , revalidated all the upgraded equipm ent. Accroding to the revalidation, all the upgraded equipm ent is m ore econom ical, ef ficient and controllable for Oral Liquid producing while satified the requirement of GMP better.Revalidation for the process of Heat Qingrejiedu Oral Liqu id production have been performed according to the up graded equipment and related system, the work scope, m ethod and flow for revalidation ha ve presented here. According to the revalidation, producing the Oral Liquid according to th e optim ized process b y upgraded equipment is more stable for control the quality of production.According to the study, the optimized process and upgraded equipm ent is more controllable, economical and efficient for Oral Liquid production.更多还原