輸入藥品製造廠定期檢查之書面審查管理與探討   全文下載

Survey on the Routine GMP Assessment for Foreign Pharmaceutical Manufacturers in Taiwan

為確保輸入藥品之製造品質，維護國人用藥安全，衛生福利部食品藥物管理署依藥事法相關規範對藥品製藥工廠執行GMP檢查並進行後續追蹤管理，以確認製藥工廠品質系統之運作持續符合GMP。對輸入藥品製造工廠之後續追蹤管理措施，與國際趨勢及國內GMP管理政策同步，從92年執行「工廠確效作業資料審查」、97年實施「PIC/S GMP符合性檢查」至101年度全面開辦「國外藥廠GMP定期檢查」持續精進，凡取得我國PIC/S GMP核准函之輸入藥品國外製造廠均納入定期檢查對象。本研究以書面審查案為分析對象，彙整105-112年辦理定期檢查之案件，評估審查案件之申請案數量趨勢、審查結果、註銷原GMP核准及常見缺失樣態等，透過分析檢視現行措施的有效性，並做為未來持續精進對於輸入藥品國外製造廠之管理制度及提升管理效能之參考，以持續增進民眾用藥安全。

To ensure the manufacturing quality of imported pharmaceuticals and safeguard the medication safety of public health, the GMP compliance state of foreign pharmaceutical manufactures, who intended to the export medicinal products to Taiwan should be accessed by TFDA. Additionally, TFDA performs subsequent follow-up management in accordance with the relevant regulation s of Pharmaceutical Affairs Act. This is to ensure that the operation of the quality systems in pharmaceutical manufacturing plants continues to comply with GMP standards. The subsequent monitoring and management mechanism including:“Factory Confirmation Operation Data Review”since 2003,“PIC/S GMP Compliance Review”implemented since 2008 to align with upgraded GMP standards to PIC/S GMP, and then the“Routine GMP Assessment of Foreign Pharmaceutical Manufacturers”has been comprehensively conducted since 2012. All foreign pharmaceutical manufacturers that have obtained the PIC/S GMP compliance letter issued by TFDA are subject to routine inspections. This study primarily focuses on desk-top inspections, compiling cases during the years 2016-2023 that underwent periodic inspections. It evaluates trends in the number of applications, review results, GMP approval cancellations, and common deficiencies. The study assesses the effectiveness of current measures and serves as a refence for continuously elaborating the GMP assessment system of imported pharmaceuticals and improving its effectiveness to further ensure the safety of medication for the public in the future.