我國原料藥藥商實施西藥優良運銷準則現況及管理之探討   全文下載

Study on Current Status of Good Distribution Practice for APIs by Pharmaceutical Firms in Taiwan

為健全藥品全生命週期之品質管理，延續西藥藥品優良製造規範（Good Manufacturing Practice, GMP）嚴謹品質管理精神，衛生福利部食品藥物管理署（下稱食藥署）積極推動實施藥品優良運銷規範（Good Distribution Practice, GDP），並分階段逐步納管從事西藥批發、輸入及輸出之藥商，而西藥製劑使用之原料藥品質好壞，亦攸關藥品之安全及品質，本研究探討原料藥GDP推動之策略規劃，並統計分析111年12月31日前取得運銷許可藥商之原料藥運銷作業樣態，由資料統整結果，可得知國內原料藥大多儲存於藥廠之倉庫並委外執行運輸作業，透過食藥署之GMP例行查核可加強原料藥倉庫管理，並強化藥商對於委外運輸業者之管理，以確保原料藥運銷作業符合GDP規定，相關資料可供食藥署持續推動GDP及後續管理參考，以維護國民用藥安全之公益。

To strengthen the quality management system from manufacturing through the entire lifecycle of medicinal products, the Taiwan Food and Drug Administration (TFDA) has been actively promoting the implementation of Good Distribution Practice (GDP). As the quality of active pharmaceutical ingredients (APIs) directly impacts the safety and quality of western medicinal products, this study discussed the management strategy of GDP compliance for APIs and analyze the APIs distribution activities of pharmaceutical companies up to December 31th 2022. The results showed that the majority of the APIs has been stored in the warehouse of pharmaceutical manufacturers with the transportation activities outsourced to other companies. Therefore, the authority should enhance the management of warehouse through routine GMP inspections, and strengthen the management of pharmaceutical companies on outsourced activities to ensure their compliance with GDP regulations. Relevant information could be used to promote the full implementation and follow-up management of GDP compliance, to ensure the quality and the safety of medicinal products for public use.