我國實施藥品優良運銷規範制度之研究   全文下載

A Study on the Implementation of GDP on Medicinal Products in Taiwan

為確保藥品出藥廠後其儲存及運輸過程之品質，健全整個藥品供應鏈管理，許多國家已立法實施藥品優良運銷規範（GDP），將藥品品質管理制度涵蓋整個藥品生命週期。我國於104年7月16日公告「西藥藥品優良製造規範（第三部：運銷）」，並於105年2月18日公告「西藥藥品優良製造規範（第三部：運銷）之施行項目及時程」，自105年7月1日開始執行GDP查核，建置完整之藥品供應鏈，維護藥品供應至病患前之品質與完整性，為民眾用藥安全把關。本研究探討GDP推動過程之制度規劃及分析GDP檢查現況，並由問卷調查結果及統計，可知大部分業者已知政府推動實施藥品GDP政策，並持正向支持態度，但對於GDP及其品質系統概念仍然薄弱，主管機關仍應持續辦理相關訓練課程，協助並強化業者對GDP的概念及實務作業。

To ensure the quality of medicinal products during storage and transportation after leaving the manufacturing plants and strengthen the management of the entire supply chain, many countries have implemented Good Distribution Practice (GDP) guidelines. On 16th July 2015, the Ministry of Health and Welfare (MOHW) announced the “Guide to Good Manufacturing Practice (GMP) for Medicinal Products (Part III: Distribution)”. Subsequently, the “Implementation Items and Schedule of the Guide to Good Manufacturing Practice for Medicinal Products (Part III: Distribution)” was announced on 18th February, 2016. The Taiwan Food and Drug Administration (TFDA) started conducting GDP inspections since 1st July, 2016 to establish a complete supply chain management of medicinal products and ensure the quality and safety of medicinal products. In this study, we discussed the planning of the promotion of GDP and analyzed the current GDP inspection status. From the survey results, it was observed that most companies are aware that the government is promoting the implementation of GDP for medicinal products and show positive support. However, their knowledge of the GDP and quality system is weak. Therefore, the authority should continue to hold training courses to assist and strengthen their knowledge and operational work.