我國西藥優良運銷作業冷鏈藥品管理與查核結果分析   全文下載

The Analysis on the Current Situation of GDP Management System for Cold Chain Medicine in Taiwan

為健全國內西藥藥品運銷品質管理，保障民眾用藥安全，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藥品批發、輸入與輸出之藥商；考量冷鏈藥品之儲存與運輸屬於高風險作業，衛生福利部公告經銷冷鏈藥品之販賣業藥商應於2021年12月31日前符合GDP規定。本研究統計分析冷鏈藥商之GDP實地查核缺失，並依GDP之章節進行分類，探討業者常見的缺失項目。缺失統計結果以第三章「作業場所及設備」最多（28.63%），其次依序為第五章「作業」（16.67%）、第一章「品質管理」（10.54%）、第九章「運輸」（7.83%）、第二章「人事」（6.55%）及第七章「委外作業」（6.41%），相關資料可供食藥署持續推動GDP符合性管理參考，以維護國民用藥安全之公益。

To improve the distribution management system of medicinal products and to ensure the quality and the safety of medicinal products for public in Taiwan, the Food and Drug Administration (TFDA) has actively been promoting the implementation of Good Distribution Practice (GDP). This study evaluated every deficiency found from GDP on-site inspections on pharmaceutical companies involved coldchain medicine between January 1st, 2020 and December 31th, 2021. The results showed the top cited deficiencies were regarded to Chapter 3 “Premises and Equipment” (28.63%), followed by Chapter 5 “Operations” (16.67%), Chapter 1 “Quality Management” (10.54%), Chapter 9 “Transportation” (7.83%), Chapter 2 “Personnel” (6.55%) and Chapter 7 “Outsourced Activities” (6.41%). In the future, the TFDA will continuelly supervise the implementation of GDP to ensure the quality and the safety of medicinal products for public.