血液製劑封緘作業可行性之研究——輸入血液製劑之品質調查

INVESTIGATION OF IMPORTED BLOOD PRODUCTS

本局依藥事法第七十四條執行之生物製劑檢驗封緘業務，因限於人力，原先只針對國產之疫苗及血液製劑實施逐批檢驗封緘，自民國七十九年一月起，則將其範圍擴大至進口之疫苗產品。近年來，由於生物科技之進步，一些血液中可能潛存的致病因子已逐漸瞭解，各項有關之檢驗技術亦逐漸被研究開發出來。而血液製劑其原料來源為人血漿、血清或動物來源血清抗體之生物製劑類，為確保用藥之安全，本局自本年度間開始進行評估進口血液製劑實施逐批檢驗封緘之可行性。為了解市售輸入血液製劑之品質，於85年3月至5月抽購檢體39件：含靜脈注射人免疫球蛋白製劑4件（測蛋白質含量、白喉抗毒素效價及麻疹抗體效價）、人血清白蛋白製劑19件（測蛋白質含量）、人血漿蛋白製劑6件（測蛋白質含量）、冷凍乾燥第八凝血因子製劑9件及冷凍乾燥第九凝血因子製劑1件（測效價），結果均符合85年度修訂生物製劑檢驗基準之規定。另外，除了將各製造廠提供之檢驗規格依類別作成比較表外，並調查統計近三年進口血液製劑品目、批次及批量，以評估如進行逐批檢驗封緘所需之人力配備。就目前所獲得之資料來看，84年由廠商所進口之血液製劑若實施逐批檢驗封緘，其增加之工作量（169批號／198批次）超過我國84年度之疫苗及國產血液製劑之逐批檢驗封緘量（140批次）。為因應「'施加福'人免疫球蛋白」案，血液製劑實施逐批檢驗封緘已勢在必行。根據研究之結果，如HCV RNA PCR等實驗法之建立，應有助於作業之推展。同時我國血液製劑已要求廠商提供病毒不活化／去除過程處理步驟及確效資料，並將逐步以書面審查作業方式，以FDA對血液製劑之管理為藍本，可逐步簡化封緘作業之檢查項目。人力不足方面：在行政院仍實施人力減肥的政策下，目前暫時先就本局內部人員調整支援，同時將在八十七年度預算中爭取增列預算員額，以執行相關之檢驗封緘。至於檢驗（如C型肝炎病毒核糖核酸之聚合酶連鎖反應測定法）所需之各項軟、硬體設施（包括儀器之購置及實驗室之改裝）等，將配合政策及本計畫逐步建立之。

According to Article 74 of the law of Pharmaceutical Affairs, vaccines and blood products used in this country, whether domestically manufactured or imported, must be tested for batch certification. However, due to a limited budget and lack of human resources, initially only domestically manufactured vaccines and blood products were tested, with the imported vaccines not being tested until 1990. To determine the quality of the imported blood products, 39 lots of different blood products were purchased randomly from the importers and various tests were conducted, The samples included 4 lots of intravenous human immunoglobulin (tested items included protein content, diphtheria antitoxin potency, and measles antibody potency), 19 lots of human albumin (protein content was tested), 6 lots of human plasma protein fraction (protein content was tested), 9 lots of freeze-dried coagulation factor VIII (potency was tested) and one lot of freeze-dried coagulation factor IX complex (potency was tested). All the samples met the requirements of the 'Formulation and Amendment of Requirements for Biological Products' as amended in 1996. To ensure the quality and safety of imported blood products, we compared the specifications of blood products from different licensde manufacturers. In addition, we also assessed the requirement of personnel and equipment, and calculated the items, lot numbers, and lot quantities of blood products imported from 1993 to 1995 to evaluate the feasibility of conducting testing prior to lot-release in the future. We conclude that the workload in conducting lot-release testing for imported blood products will be even heavier than that for both vaccines and domestically manufactured blood products, which are already tested regularly. Since lot-release testing for improted blood products is a fixed policy which will be enforced in the quite near future, we conclude that to raise the budget in 1998 and recruit at least 4 new members of staff is an urgent necessity.