药品清洁验证中残留物检测的分析方法选择
Determination of the Analysis methods of drug residue in cleaning validation
管玉华 1徐春明1
作者信息
- 1. 223003 淮安，江苏天士力帝益药业有限公司
- 折叠
摘要
药品生产企业在每道工序完成后，需要对生产设备进行清洁，对残留物进行检测，而检测方法的选择一直是困扰企业的一个难题。本文对残留物进行简单分类，给出了一些通用的选择方法，同时结合实际情况，灵活选择。
Abstract
Pharmaceutical manufacturing enterprises are often trapped by the cleaning validation of manufacturing equipments of which the analysis method for residue detection is often hard to select. In this article, depending on the actual situations, residues are preliminarily classified as well as their corresponding versatile selecting plans of the analysis method are also given out.
关键词
药品生产企业/设备清洁/残留物/检测方法Key words
Drug manufacturing enterprise/Cleaning of equipment/Residues/Analysis methods引用本文复制引用
出版年
2013
NETL
NSTL
维普
万方数据