可见异物检查法有关问题的探讨

Discussion of Related Problems in Practical Work For The Method of Obviously Foreign Matter Inspection

随着《中国药典》2005年版的实施,注射剂可见异物检查的不合格率明显上升,导致在监督抽查中注射剂抽验的比例大大提高。本法中的结果判断存在掌握尺度不准和检验人员的主观性太大等问题。

Along with the implementation of the China Pharmacopoeia in 2005, the unqualified ratio of the injection for obvious foreign matter inspection rise obviously, causing the proportion to enhance greatly at the surveillance inspection of spot checking the injection . The judgement of the result of this method shows that problems such as the inaccurate scale of control and the subjectivity of inspectors.