皮内注射用卡介苗生产场地变更质量可比性研究

摘要

目的 对发生场地变更的皮内注射用卡介苗产品进行关键质量要素对比和分析,确认变 更后产品质量与变更前一致.方法 对新老车间卡介苗产品关键质量指标进行分析,同时对卡介苗成品稳定性、卡介菌结构特异性、卡介苗成品动物安全性等方面进行比较研究.结果 新老车间卡介苗产品的关键质量指标均符合相关规定要求,其中新车间卡介苗半成品沉降率为4.55％～10.00％,半成品活菌数为(1.82～2.93)×107菌落形成单位/mg,成品活菌数为(3.34～4.97)×106菌落形成单位/mg,均在老车间历史数据警戒限范围以内.新老车间生产的卡介苗成品的稳定性、卡介菌结构特异性和产品安全性等实验结果 均符合相关规定要求.结论 卡介苗生产场地变更未对产品质量产生不利影响.%Objective To compare the key quality indicators of BCG vaccine for intradermal injection (BCG) products before and after site change,to ensure product quality in the change.Methods Major quality parameters measurements of bacterium produced in new and old workshops were analyzed.The final product stability,bacterium structural characteristics,and safety in animals were compared.Results Major quality parameters of bacterium products from both new and old workshops met relevant requirements.Semi-finished BCG from new workshop had sedimentation rates at 4.55％-10.00％ and culturable particle counts at (1.82-2.93) × 107 colony-forming unit (CFU)/mg,while final products had culturable particle counts at (3.34-4.97) × 106 CFU/mg.All of which were within the alert range calculated from old workshop data.The stability,structural specificity,and safety of BCG produced by both new and old workshops all met requirements.Conclusion The change of BCG production site has no adverse effect on product quality.