| Summary: | 碩士 === 國立交通大學 === 管理學院運輸物流學程 === 106 === 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.
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