CAJ | 학술논문

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.
목적 대을형뇌염(을뇌)감독활역묘생산과정중사용적공예액체진행계통험증,학보기배제과정화저존과정적일치성.방법 근거공예액체재생산중시부접촉혹진입산품,학정험증주요침대8충관건공예액체.침대제비화저존과정중영향액체질량적변량건립공예삼수,병근거액체재생산중적용도건립능반영공예액체질량적표준.통과계통성실험수집수거래증명액체제비화저존과정공예삼수적가행성.결과 재대8충관건공예액체매충각3차적혼합균일성험증중,매차9개양품적상대표준차균＜5％,병차8충액체매충각3비재경과최장가능저존시간후,양품검정결과균부합가접수표준.결론 험증증명료채용을뇌활역묘관건공예액체적제비정서능배제출균일병부합공예요구적액체,차매충공예액체균능재규정적저존조건하재최장저존시간내유지질량은정,종이위질량、안전성화유효성도부합중국약전급WHO표준적을뇌활역묘생산제공료보장.
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.Methods Eight critical process solutions were chosen 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 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 solutions 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.