醫藥物流服務業者因應PIC/S GDP規範 在倉儲作業之改善與風險管理之研究

A Study of Warehouse Operations Improvement and Risk Management of the Pharmaceutical Service Provider According to PIC/S GDP

鄭仙平(Hsien-Ping Cheng)

指導教授 ： 姚銘忠

國立交通大學/管理學院/管理學院運輸物流學程/碩士(2018年)

摘要

為符合PIC/S GDP規範要求並提升醫藥物流品質，衛生福利部食品藥物管理署參考PIC/S GDP，正式公告「西藥藥品優良製造規範（第三部：運銷）」。本研究探討醫藥物流業者因應新法的施行，如何在推行GDP的過程中能掌握必要的條件，以符合要求並順利通過驗證，以及如何在品質管理、作業場所與設備以及運輸之溫度監控等等的醫藥物流作業中，鑑別並降低高風險因子以能提升整體作業品質。故本研究先收集PIC/S GDP輔導性訪查之作業缺失，運用風險矩陣表以PIC/S GDP各章節為要因，分析違反PIC/S GDP規範之作業行為及在作業上要能排除好發的不當操作行為，以能通過食藥署的查驗。另外，本研究繪製以部門為分類的作業失誤失效之風險矩陣表，運用失效模式與效應分析 (Failure Mode and Effect Analysis, FMEA)鑑別各作業區段的風險，將現行作業流程改善為合理化作業流程，再針對風險分數最高的六個項目進一步改善以成為再優化之作業流程，達成降低風險並提升作業品質之目的。本研究所提出的方法在個案公司的實證下，可大幅降低原有作業風險。故本研究所建立流程與步驟，可以提供醫藥物流業者參考，降低作業風險並提高作業品質。

關鍵字

PIC/S GDP ； 醫藥物流 ； 流程改善 ； 失效模式與效應分析

並列摘要

TFDA had proclaimed PIC/S GDP Regulations for the purpose of providing the guidances and requirements for the improvement in pharmaceutical logistics quality. The thesis study how the pharmaceutical logistics service provider should respond to the guidances of GDP so as to catch the crucial condition and conduct the requried action to get approval of certification and, also, to identify the factors with high risk in the operations processes of quality assurance, premises, equipment, and temperature control during distribution to improve overall quality of pharmaceutical logistics. In this study, we first summarize the the records of fault collected from PIC/S GDP pre-audit, and use the first Risk Matrix that categorizes the records of fault following the chapters in PIC/S GDP Regulations to prevent possible faults so as to pass the PIC/S GDP audit by TFDA. We also prepare the second Risk Matrix that classifies the faults in the operations processes by the departments, and apply the technique of Failure Mode and Effect Analysis (FMEA) to evaluate the risks, propose To-Be processes from their As-Is versions, and do further polishing by improving those top-six factors with largest risk number to obtain the Best-on-Hand processes. By applying the proposed framework to the case company, we verify that it may significantly reduces the risks in the operations processes. Therefore, the proposed framework may assist the pharmaceutical logistics service providers to monitor the risks and improve quality in their distribution processes.

並列關鍵字

PIC/S GDP ； Pharmaceutical Logistics ； Process Improvement ； Failure Mode and Effect Analysis

參考文獻

英文部分

1. Anand Pillay and Jin Wang (2003), “Modified failure mode and effects analysis using approximate reasoning,” Reliability Engineering & System Safety, Vol. 79, No. 1, pp. 69-85.

2. El Mokrini, E.Dafaoui, A.Berrado and A.El Mhamedi (2016), “An approach to risk Assessment for Outsourcing Logistics Case of Pharmaceutical Industry,” IFAC-PapersOnLine, Vol. 49, No. 12, pp. 1239–1244.

3. El Mokrini, N. Kafa, E. Dafaoui and A. El Mhamedi, A. Berrado (2016), “Evaluating outsourcing risks in the pharmaceutical supply chain Case of a multi-criteria combined fuzzy AHP-PROMETHEE approach,” IFAC-PapersOnLine, Vol. 49, No. 28, pp. 114–119.

4. Elif Kongar, Ece Haznedaroglu, Osama Abdelghany, Mert Ozan Bahtiyar (2014), “A novel IT infrastructure for reverse logistics operations of end-of-life pharmaceutical products,” Information Technology and Management, Vol. 16, No. 1, pp. 51-65.