101-103年輸入藥品製造廠GMD符合性之追蹤調查

藥品品質攸關國民健康，為確保製藥品質及民眾用藥安全，並掌握國外藥廠之動態，衛生福利部食品藥物管理署(前行政院衛生署食品藥物管理局，以下簡稱TFDA)，自101年起開始辦理輸入藥品製造廠後續管理之定期GMP檢查，凡取得我國PIC/S GMP核備之輸入藥品國外製造廠均納入定期檢查對象，檢查方式採書面審查或實地查廠之方式雙軌並行，以確認其是否持續符合GMP規範。101年至103年，TFDA共辦理908案之輸入藥品國外製造廠後續GMP定期檢查-書面審查，及21廠次後續GMP定期檢查-實地查廠案。統計分析前述案件之檢查結果、常見缺失及註銷原GMP核備樣態，並探討輸入藥品國外製造廠之持續GMP符合性，檢查結果共註銷153張GMP核備函，且查獲1家國外藥廠有嚴重違反GMP之情事，連結相關產品限制通關與許可證處理等作業，可有效達到確認輸入藥品國外製造廠持續GMP符合性之目的。TFDA將持續追蹤輸入藥品國外製造廠之GMP符合性，並精進對於輸入藥品國外製造廠之管理制度，以期提升管理效能，確保民眾用藥安全及品質。

關鍵字

藥品優良製造規範；後續檢查；定期檢查；國外藥廠

並列摘要

Since 2012, the Taiwan Food and Drug Administration (TFDA) has enforced routine GMP assessment of overseas pharmaceutical manufacturers with PIC/S GMP approval letter issued by Ministry of Health and Welfare either by desktop review or on-site inspection to verify its continuous GMP conformance. From 2012 to 2014, 908 desktop reviews and 21 on-site inspections were performed by TFDA. The results, including frequently found deficiencies and the GMP conformance were analyzed and discussed in this report. 153 GMP approval letters has been withdrawn, and one overseas manufacturer was found non-compliance by on-site inspection. It highlights the objective of routine GMP assessment was achieved by banning the importation and followed action to its product licenses of those medicinal products without the manufacturer’s GMP compliance. TFDA will continue routine GMP assessment and elaborate the effective management of the overseas pharmaceutical manufacturers to oversight the manufacturing and quality controls thus provide continuous confidence to the public of the manufacturer’s compliance with PIC/S GMP standards.

並列關鍵字

Good Manufacturing Practice ； PIC/S GMP ； routine GMP Assessment ； overseas foreign pharmaceutical manufacturer

國際替代計量

101-103年輸入藥品製造廠GMD符合性之追蹤調查

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