Analysis on the Quality Problems of Shanghai Hospital Preparations from 2004 to 2007
- VernacularTitle:2004～2007年上海市医院制剂中抽验不合格制剂质量问题分析
- Author:
Furong AN
- Publication Type:Journal Article
- Keywords:
Hospital preparations;
Quality problems;
Spot check results
- From:
China Pharmacy
2007;0(28):-
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:To provide reference for the enhancing of the quality of hospital preparations.METHODS:The disqualified reports on Shanghai hospital preparations published in "Shanghai drug and medical equipment quality bulletin" between 2004 and 2007 were collected to investigate the main quality problems.RESULTS:A total of 105 batches(19 dosage forms were covered)of unqualified preparations were reported in spot checks,of which,74(70.5%)were external preparations,17(16.2%)oral preparations,and 14(13.3%)sterility preparations.The common unqualified items include package amount(34.5%),description(15.4%),content(15.4%),pH value(13.6%),and microbial limit(8.2%).The major quality problems were related to package containers and technology.CONCLUSIONS:It is suggested that the concerned department to tighten control on quality of hospital preparations aimed at the above-mentioned problems.
