頁籤選單縮合
題 名 | 某精神科醫院藥物不良品通報分析=Analysis of the Medical Defect Products System in a Psychiatric Hospital |
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作 者 | 賴威廷; 鄭淑文; | 書刊名 | 藥學雜誌 |
卷 期 | 30:4=121 2014.12[民103.12] |
頁 次 | 頁132-136 |
分類號 | 412.24 |
關鍵詞 | 藥物不良品通報; 國際醫藥品稽查協約組織藥品GMP法規; 藥物安全監視; Substandard drugs; Drug safety; |
語 文 | 中文(Chinese) |
中文摘要 | 民國71年起政府公告實施藥品 GMP,88年公告「藥品優良製造規範 cGMP」, 104年將全面實施 PICS/GMP,大幅提升國內藥品製造廠從製造、品質管理到風險管 理的能力,並增加全球市場的競爭力。藥品在製造過程中,除了須符合相關規定外, 在藥品上市後,品質監測、不良品通報與回收也是確保藥物品質相當重要的一環。藉 由藥物不良品通報之探討,可分析的資料內容包括藥品資料、產品 缺陷之描述、藥 品劑型、廠商處理方式等相關問題,了解整個藥物不良品系統通報的成效,希望未來 能進一步提升產品品質,以維護國人用藥安全。 |
英文摘要 | Pharmaceutical GMP was announced for implementation by the government since 1982. The GMP for Medicinal Products was announced in 1999, and the PICS/GMP will be comprehensively implemented in 2015 to substantially improve the capability of Taiwan pharmaceutical manufacturers in all aspects from manufacturing, quality control to risk management and increase their competitiveness in the global market. The manufacturing process of drugs must follow relative regulations, and in addition, quality inspection, product defect reports and recall also play important roles in guaranteeing the quality of drugs. Based on the medical product defect reporting system, the study was designed to learn about the effectiveness of the medical product defect reporting system through analyzing relative issues such as the data on drugs, description of product defects, the form of drugs and solutions of manufacturers, expecting to further improve product quality in the future to guarantee drug safety in Taiwan. |
本系統中英文摘要資訊取自各篇刊載內容。