药品灯检机Knapp测试的原理及应用
Principle and Application of the Knapp Test for Drug Lamp Inspection Machine
邵铖祎 1季晨姣 1王谷明1
作者信息
- 1. 常州千红生化制药股份有限公司,江苏常州 213000
- 折叠
摘要
本文对药品灯检和Knapp测试的历史发展进行了阐述,随后介绍了Knapp测试的原理和方法.对Knapp测试中的样品选取进行了讨论,对于随机化方式和荧光标记进行了推荐.对测试结果进行分析,提出样品累计数-检出率图的方式可以更加直观和全面地比较机器灯检和人工灯检的效能;对《药品GMP指南》中的机器灯检和人工灯检效能比(FQB/FQA)与其他计算方式进行了对比,确证了《药品GMP指南》对于机器效能的要求更加严格.
Abstract
This article elaborates on the historical development of drug lamp inspection and the Knapp test,followed by an introduction to the principles and methods of the Knapp test.It discusses the selection of samples in the Knapp test,and recommends randomization methods and fluorescent labeling.The analysis of test results suggests that the cumulative sample count-detection rate graph can provide a more intuitive and comprehensive comparison of the efficiency of machine lamp inspection and manual lamp inspection;a comparison is made between the efficiency ratios of machine lamp inspection and manual lamp inspection(FQB/FQA)in the Drug GMP Guidelines and other calculation methods,confirming that the Drug GMP Guidelines have stricter requirements for machine efficiency.
关键词
灯检机/Knapp测试/原理/效能/应用Key words
lamp inspection machine/Knapp test/principle/efficiency/application引用本文复制引用
出版年
2024
NETL
NSTL
万方数据