生物反应器在设计、制造和使用过程中的质量控制及验证策略探讨

Quality Control and Strategy Validation in Design,Manufacture and Application of Bioreactor

根据生物反应器的工艺特点,分析和讨论了质量控制和GMP合规性的策略和要求,介绍了机械搅拌式发酵罐在设计、制造、安装、调试和确认、使用各阶段的主要质量活动、关键控制要点以及制药行业特殊的检验、试验及验证要求,并总结了符合标准和GMP法规的生物反应器文件要求。

In accordance with the characteristics of bioreactor,in this article,the strategy and requirements in quality control and GMP compliance were analyzed and discussed.For mechanical agitating fermentation vessel,the main processes involved in quality control in the stages of design,manufacture,assembly,commissioning and qualification,and application were introduced.Some special requirements in inspection,testing and validation for the equipment used in pharmaceutical industry were also stated.The requirements for the document for bioreactor so as to compliance with the standards and GMP rules were summarized.