有关装量差异验证方法的讨论  

Discussion on the verification method for loading difference

作　　者：陈尔东 黄红琴 葛君 于阳阳 欧阳健 Chen Erdong;Huang Hongqin;Ge Jun;Yu Yangyang;Ouyang Jian(WuXi Biologics Conjugation Co.,Ltd,Wuxi 214000)

机构地区：[1]无锡药明偶联生物技术有限公司,江苏无锡214000

出　　处：《化工与医药工程》2021年第2期39-42,共4页Chemical and Pharmaceutical Engineering

摘　　要：在药品生产的过程中,装量差异是一个关键的中间控制指标,通过利用工序能力指数的方法进行装量差异的分析,提供工序能力指数方法可行性的分析,利用科学有效且便捷的方式以取代传统的验证方式。In the process of drug production,loading difference is a key intermediate control index.In this paper,loading difference by using the process capability index method was analyzed.The feasibility analysis of the process capability index method was provided.And the traditional verification method was replaced by the scientific,effective and convenient way.

关 键 词：验证 装量差异 工序能力指数不良率 

分 类 号：R979.9[医药卫生—药品]