航空貨運場站醫藥物流作業規劃與風險評估

Abstract

為確保藥品在運銷過程可以維持品質及包裝的完整性，國際醫藥品稽查協約組織（PIC/S）頒布Good Distribution Practice (GDP)，台灣衛生福利部亦公告「西藥藥品優良製造規範（第三部：運銷）」以與國際接軌，然台灣航空貨站因通關制度與環境之差異，不易取得國內或國際的藥品運輸認證。 爰此，本研究運用失效模式與效應分析 (Failure Mode and Effect Analysis, FMEA)模式，邀專家學者評估桃園國際航空貨站現行藥品作業失效風險，確認依相關藥品規範及客戶需求等標準所提之改善建議，得以管理失效風險，進而提出台灣航空貨站醫藥物流作業環境與流程規劃方案。 現行台灣航空貨站藥品作業潛在有不符藥品作業規範、無法啟動藥品作業及未落實溫控程序等嚴重失效模式，本研究針對相對較高之風險失效因素提改善建議，經與專家學者確認，可有效降低資訊、規範、空間、設備及貨站法規等失效發生頻率，確保規劃之藥品作業環境與流程，達到改善現行作業風險，符合藥品規範之目標。

To ensure pharmaceutical quality and packaging integrity during transportation, the Pharmaceutical Inspection Convention and Pharmaceutical Co-operation Scheme introduced “Good Distribution Practice-GDP”. Parallel to the international standard, Taiwan Food and Drug Administration enacted “Pharmaceutical Good Manufacturing Practice” to ensure Taiwan’s relevant regulations meet international guidelines. However, constraints due to existing custom clearance requirements prevent Taiwan airport cargo terminals from being certified by international or domestic agencies governing pharmaceuticals handling and transportation.

As such, “Failure Mode and Effect Analysis” (FMEA) is utilized to assess the inadequacies and associated risks based on experts’ survey and suggestions for pharmaceuticals handling processes at Taoyuan International Airport Cargo Terminal. The goal is to identify and manage associated risks and to propose a plan that meets internal and domestic pharmaceutical handling and transportation guidelines, for operational processes in Taiwan’s air cargo terminals.

The FMEA results indicate areas of concern and countermeasures are therefore proposed to mitigate deficiencies and warrant certification by internal and domestic agencies governing pharmaceutical transportation and handling.