輸入藥品製造廠GMP實地查廠結果分析

Overseas Pharmaceutical Manufactures onsite GMP Inspection Results Analysis

為確保製藥品質及民眾用藥安全，衛生福利部食品藥物管理署（以下簡稱TFDA）辦理輸入藥品國外製造廠之實地查廠，赴廠確認相關製造作業符合GMP規範，以加強輸入藥品製造廠之管理。97至104年間TFDA計赴38個國家，共執行213廠次實地查核，統計其查核結果，平均通過率為95%；並進一步探討各種缺失嚴重程度及常見缺失內容。缺失類別中以「廠房設施與設備」及「生產」所占比例最高，其中「廠房設施與設備」相關缺失中又以涉及「製造及品管實驗設備」項目最為常見，而「生產」之缺失中以「查核現場產品之製程、重要管制項目、人員等執行情形未能符合規定」及「查核劑型/品項相關製程確效及清潔確效作業未能符合規定」兩項最常見。藉由GMP實地查廠，可達到確認輸入藥品國外製造廠符合GMP之目的，亦可有效攔阻劣質藥品輸入國內。TFDA將持續追蹤輸入藥品國外製造廠之GMP符合性及精進輸入藥品國外製造廠之相關管理制度，期有效運用資源，提升管理效能，並確保輸入藥品品質與維護民眾用藥安全。

To ensure the safety, quality and efficacy of medicinal products for Taiwan consumers, the Taiwan Food and Drug Administration (TFDA) under the Ministry of Health and Welfare is responsible for regulating medicinal products supplied in Taiwan meet acceptable standards. An overseas on-site inspection may be conducted by TFDA to verify that the facility and manufacturing activities is at an acceptable level of GMP compliance. This report analyzes the inspection results and the deficiencies found from 213 overseas inspections in 38 countries during the period of 2008-2015. The average rate of GMP compliance of inspected overseas manufactures is 95%. In accordance with the PIC/S GMP Guide, all deficiencies found during inspections were classified into 9 categories. The deficiencies related to ＂Premises and Equipment＂ was highest in ranking, and the Qualification and maintenance of Equipment for production and analytical testing issues were the frequently found deficiencies. The second highest ranking was ＂Production＂, and the manufacturing process, in-process control, personnel, process and cleaning validation issues were frequently found deficiencies. TFDA will continue routine GMP assessment and elaborate effective management of the overseas pharmaceutical manufacturers to ensure medicinal products supplied in Taiwan meet acceptable standards.