107年度血液製劑檢驗封緘案件分析   全文下載

Annual Surveillance of Batch Release of Blood Products in Taiwan, 2018

本報告係食品藥物管理署（下稱食藥署）107年度執行生物藥品中血液製劑檢驗封緘案件之統計分析，以瞭解國人使用之血液製劑整體品質概況，並確認各血液製劑品質均能符合中華藥典或原廠之規範。107年度放行血液製劑檢驗封緘產品共145批，經現場查核儲運溫度並抽樣檢體後，已完成檢驗總計放行1,175,986瓶，經逐批進行檢驗與審查，結果均符合中華藥典或原廠規範，合格率100％，並核發封緘證明書，供國人用於治療或預防相關疾病。血液製劑主要可分為四大類，白蛋白注射劑、免疫球蛋白注射劑、凝血因子注射劑及纖維蛋白止血組；統計107年度申請檢驗封緘之批數及總數量最多者為白蛋白注射劑；在國血製劑方面，檢驗封緘數量以人類免疫球蛋白注射劑最多，占總數量66.97％。透過統計分析與探討，國人血漿所製備之免疫球蛋白注射劑供應尚足以供國人使用，也是落實國血國用政策之典範。

This report summarizes the batch released blood products in Taiwan in 2018. 18 items and 1,378 tests were conducted in order to evaluate 145 batches of blood products, which included a total of 1,175,986 bottles. All the results complied with the specifications listed in the Chinese Pharmacopeia or the respective company's specifications. These 145 batches belonged to 30 licensed products. In brief, the top three batches of blood products were albumin, fibrin sealant kit and hepatitis B immunoglobulin, and the three highest quantities of blood products were albumin, intravenous immunoglobulin and fibrin sealant kit. In addition, 66.97% bottles of intravenous immunoglobulin, 7.39% bottles of albumin, 11.52% bottles of factor VIII, and 100% bottles of factor IX, were prepared from human plasma obtained out of voluntary blood donors in Taiwan.