94-96年度中藥製劑國產查驗登記及抽查檢驗案件分析

Analysis on Chinese Medicinal Preparations of Registration and Inspection Cases in Fiscal Years of 2005 to 2007

秦玲(Ling Chin) ； 黃成禹(Cheng-Yu Huang) ； 林哲輝(Jer-Huei Lin)

《藥物食品檢驗局調查研究年報》 26號 (2008/12) Pp. 98-101

https://doi.org/10.6946/ASRNL.200812.0098

摘要

本分析報告蒐集94年1月至96年12月間中藥製劑查驗登記案件及各地方衛生機關送本局檢驗抽查案件之檢驗結果，予以統計分析。結果顯示查驗登記案件以94年度628件最多，抽查案件是95年度129件最多，這二類案件總件數以94年度736件居冠。3年來平均不合格率，抽查案件的6.1%顯然比查驗登記的0.51%比例高。不合格項目方面，查驗登記案件以鑑別項7件最多，抽查檢驗方面則以鑑別項及平均重量項各4件居多。

關鍵字

中藥製劑 ； 查驗登記案件 ； 抽查案件

並列摘要

In this report, analysis data were complied on samples of Chinese medicinal preparations of registration and samples acquired by the local health bureau officers from fiscal year 2005 to 2007.
The results were as following. The highest number of registration case was 628 in 2005, and the highest number of inspection case was 129 in 2006. The highest number of total cases was 736 in the fiscal year 2005. The percentage of inadequate was 6.1% in the inspection cases which was higher than the 0.51% in registration cases.
In terms of failing to comply with the requirements, for registration categories, 7 cases of identification were the most serious, for inspection categories, 4 cases of average weight and identification were the most serious cases.

並列關鍵字

Chinese medicinal preparations ； registration case ； inspection case