乙型脑炎减毒活疫苗生产工艺液体质量验证

 目的   对乙型脑炎（乙脑）减毒活疫苗生产过程中使用的工艺液体进行系统验证，确保其配制过程和储存过程的一致性。 方法   根据工艺液体在生产中是否接触或进入产品，确定验证主要针对8种关键工艺液体。针对制备和储存过程中影响液体质量的变量建立工艺参数，并根据液体在生产中的用途建立能反映工艺液体质量的标准。通过系统性实验收集数据来证明液体制备和储存过程工艺参数的可行性。 结果  在对8种关键工艺液体每种各3次的混合均一性验证中，每次9个样品的相对标准差均<5%，并且8种液体每种各3批在经过最长可能储存时间后，样品检定结果均符合可接受标准。 结论  验证证明了采用乙脑活疫苗关键工艺液体的制备程序能配制出均一并符合工艺要求的液体，且每种工艺液体均能在规定的储存条件下在最长储存时间内维持质量稳定，从而为质量、安全性和有效性都符合中国药典及WHO标准的乙脑活疫苗生产提供了保障。

Quality validation on process solutions used in manufacture of attenuated Japanese encephalitis vaccine

 Objective   To apply a systematic and scientific validation on process solutions used in manufacturing process of attenuated Japanese encephalitis vaccine to guarantee consistency in formulation and storage steps.   Method   Eight critical process solutions were chosed to be validated based on whether they contacted products or not. Process parameters were set up according to the variables influencing solution quality. Quality standards representing critical quality attributes of the process solution were established based on its function in production. Finally, systematic experiments were executed to prove feasibility of process parameters in formulation process and storage step.  Results   In every 3 mixing validation executions for 8 critical process solutions, the relative standard deviation of 9 samples was less than 5%. After stored for the supposed longest time allowed, all 3 batches of each solution met the acceptance criteria.  Conclusions  The validation proves that a homogeneous process solution complying with process requirements can be prepared with the formulation process. All solution can maintain stable quality under the prescribed storage conditions for the longest time, providing guarantee for production of attenuated Japanese encephalitis vaccine in accordance with the quality, safety and efficacy requirements of both Chinese pharmacopeia and WHO standard.