我國原料藥藥商之西藥優良運銷作業管理情形調查

Survey on the GDP Management System for APIs in Taiwan

黃聖淮(SHENG-HUAI HUANG) ； 傅淑卿(SHU-CHING FU) ； 謝綺雯(CHI-WEN HSIEH) ； 陳映樺(YING-HUA CHEN) ； 遲蘭慧(LAN-HUI CHIH)

《食品藥物研究年報》 12期 (2021/12) Pp. 350-357

摘要

為確保藥品運銷品質，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，因此，衛生福利部食品藥物管理署（下稱食藥署）亦逐步推動GDP政策，於104年7月16日公告「西藥藥品優良製造規範（第三部：運銷）」後，自105年7月1日起開始執行GDP查核，目前已將西藥藥廠、持有藥品許可證及批發冷鏈藥品及原料藥之藥商納入GDP管理，以強化藥品出廠後之儲存與運送品質，保障民眾用藥安全。為確保西藥製劑之原料藥運銷品質，食藥署賡續推動原料藥實施GDP，本研究係調查持有輸入原料藥許可證之販賣業藥商於食藥署分階段實施GDP制度前，對於輸入原料藥GDP認知及運銷狀況，結果發現半數以上藥商曾參與GDP教育訓練及已著手規劃實施GDP，惟對於供應藥品需留有運銷紀錄之觀念較薄弱，食藥署將持續辦理對業者之相關教育訓練，並將外部倉庫及委外作業之管理列為檢查重點，進而強化藥品運銷品質。

關鍵字

原料藥 ； 藥品優良運銷規範

並列摘要

To ensure the control of distribution chain and consequently maintain the quality and the integrity of medicinal products, many countries have established Good Distribution Practice (GDP) guidelines. On 16^(th) July 2015, Taiwan Food and Drug Administration (TFDA) announced the ＂Guide to Good Distribution Practice for Medicinal Products＂. TFDA started conducting GDP inspections since 1^(st) July 2016 to establish a complete supply chain management of medicinal products and ensure the quality and safety of medicinal products. TFDA has announced the manufacturers of western pharmaceuticals, dealers of western pharmaceuticals holding the drug permit license, active pharmaceutical ingredients (API), or wholesaling cold chain drugs shall meet the GDP. To promoted the implementation of GDP, this study surveyed the dealers of western pharmaceuticals who hold the drug import permit license about GDP awareness before implementation. It was observed that most companies were aware that the government was promoting the implementation of GDP for medicinal products and showed positive support. However, their knowledge of keeping the transaction records was weak. TFDA will continue to promote the full implementation of GDP system in Taiwan.

並列關鍵字

active pharmaceutical ingredients (API) ； good distribution practice (GDP)