Studies On The Qingrejiedu Oral Liquid GMP Validation

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.