104年度血液製劑檢驗封緘案件分析

Results from Annual Surveillance of Batch Release: Blood Products in Taiwan, 2015

本報告係食藥署104年度執行生物藥品中血液製劑檢驗封緘案件之統計分析，以了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。104年度放行血液製劑檢驗封緘產品共146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1,137,717瓶，經逐批進行19項1,666次之檢驗與審查，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。104年度放行之146批產品分別來自12間藥商所持有之33張許可證；統計104年度申請檢驗封緘之批數前3名依序為血清白蛋白、纖維蛋白止血組及B肝免疫球蛋白，總數量前3名則為血清白蛋白、免疫球蛋白靜脈注射劑及B肝免疫球蛋白；在國血製劑方面，其檢驗封緘放行數量為9批141,277瓶，佔總量12.4%。

This report presents results from the batch release of imported blood products in Taiwan in 2015. In order to evaluate 146 batches, which included a total of 1,131,717 bottles, 19 items and 1,666 tests were conducted. All of the results complied with the specifications listed in the Chinese Pharmacopeia or the respective company's specifications. These 146 batches belonged to 33 licensed products. In summary, the top three batches of blood products were Albumin, Fibrin sealant set and Hepatitis B immunoglobulin, respectively, and the three highest quantities of blood products were Albumin, Intravenous immunoglobulin and Hepatitis B immunoglobulin, respectively. In addition, there were 61,463 bottles of intravenous immunoglobulin, 72,758 bottles of albumin, 4,642 bottles of high purity factor VIII concentrate and 2,414 bottles of high purity factor IX concentrate, all of which were prepared from human plasma obtained from voluntary blood donors in Taiwan.