摘要
目的:对无菌药品参数放行的质量控制方法进行分析。方法:对比传统的质量控制方法,结合GMP的要求,对无菌药品参数放行优越性进行阐述,并提出具体的实施方法。结果与结论:在无菌药品的生产质量控制中,参数放行是比传统的控制手段更有效的方法。
Objective： To analyze the quality control technique based on parametric release of axenic medicine. Method： Comparing traditional quality control methods and combining the requirements in GMP, the advantages of parametric release method for axenic medicine were described, and mean while, the concrete methods were presented. Result and conclusion： For quality control of axenic medicine production, the method of parametric release is more effective than traditional method.
出处
《医药工程设计》
2007年第4期1-4,共4页
Pharmaceutical Engineering Design
关键词
无菌
GMP
参数放行
axenic
GMP
parametric release
