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无菌原料药生产工艺验证过程的研究
引用本文:梁毅,贺聪.无菌原料药生产工艺验证过程的研究[J].中国药房,2012(41):3849-3852.
作者姓名:梁毅  贺聪
作者单位:中国药科大学国际医药商学院,南京210009
摘    要:目的:为无菌原料药企业开展无菌工艺验证提供参考。方法:根据国内、外期刊文献及企业培训资料,探讨无菌原料药生产工艺的验证过程。结果与结论:无菌原料药工艺模拟验证的内容和方法包括工艺模拟验证的原则、工艺模拟验证方法、模拟介质的选择、模拟介质的评估、工艺模拟验证验收标准、结果调查与再验证、环境监测、验证报告等;无菌工艺验证的其他关键因素包括空调净化系统(HVAC)的验证、高效过滤器检漏等。企业要保证其生产工艺完全符合要求,生产出符合标准的原料药,就必须进行无菌工艺验证。

关 键 词:无菌  原料药  生产工艺验证  工艺模拟验证

Investigation of Validation Process of Aseptic Production Technology of Raw Material Drug
LIANG Yi,HE Cong.Investigation of Validation Process of Aseptic Production Technology of Raw Material Drug[J].China Pharmacy,2012(41):3849-3852.
Authors:LIANG Yi  HE Cong
Institution:(School of International Pharmaceutical Business, China Pharmaceutical University, Nan- jing 210009, China)
Abstract:OBJECTIVE: To provide reference for aseptic API process validation in aseptic raw material drug manufacturers. METHODS : The validation process of aseptic production technology was investigated according to the domestic and foreign jour- nals and training materials of enterprises. RESULTS & CONCLUSIONS: The simulated validation content and methods of aseptic production technology of raw material drug include the principle and methods of simulated validation, selection and evaluation of simulated medium, acceptance criteria of simulated validation, result survey and re-validation, environment monitoring, validation report, etc. The key factors of aseptic API process validation contain the validation of HVAC and high efficiency filter leak detec- tion, etc. If manufacturers guarantee that production technology is in line with requirements completely and produce raw material drug, aseptic API process validation should be conducted.
Keywords:Aseptic  Raw material drug  Production technology validation  Technology simulation validation
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