我國推動藥品優良運銷規範（GDP）管理制度與國際接軌之探討

Study on the Integration of National GDP Management System for Medicinal Products Into International Practices

林中豪(Chung-Hao Lin) ； 謝綺雯(Chi-Wen Hsieh) ； 黃琴喨(Chyn-Liang Huang) ； 李明鑫(Ming-Shin Lee)

《食品藥物研究年報》 6期 (2015/12) Pp. 406-413

摘要

為確保藥品運銷鏈之管控，進而維護藥品之品質與完整性，許多國家已立法實施藥品優良運銷規範(GDP)，國際藥品稽查協約組織(PIC/S)亦於103年6月1日正式公告藥品優良運銷規範(GDP)，我國身為PIC/S組織之一員，已參考PIC/S組織公告之法規擬訂國內藥品儲存及運銷相關規範。本研究探討食藥署推動與執行藥品GDP制度過程、教育訓練及輔導訪查等活動，藉逐步推動實施藥品GDP，健全我國與國際接軌之GMP/GDP管理制度，確保藥品品質與安全，維護民眾用藥安全。

關鍵字

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) related guidelines. On 1^(st) June 2014, Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) published Guidelines on Good Distribution Practice (GDP) of Medicinal Products for Human Use. As the participating authority of PIC/S, Taiwan FDA is to establish GDP related regulation according to these guidelines in the near future. In this study, we discussed the process for the promotion and implementation of GDP, training courses and gap assessment on GDP for medicinal products. Through step by step promotion, we can integrate our GMP/GDP system to international standard and ensure the quality and the safety of medicinal products for public.

並列關鍵字

Good Distribution Practice (GDP)