药品清洁验证中残留物检测的分析方法选择

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。%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.