一旦新藥研發企業成功取得新藥證,必將進入量產議題。面對日益嚴謹且全球同步推動之「藥物優良製造準則(Good Manufacturing Practices, GMP)」,一座新藥藥廠自規劃至落成,除了新藥製程之量化評估與可行性分析外,更必須整合業主、建築師、工程設計顧問、製程設備供應商、機電空調(無塵設備)供應商、廠房土建營造包商、以及下包商等各方機構,各自負有不同專業責任與性質迥異之工作項目;而更艱鉅的任務,則是必須通過國際性之GMP認證。因此,如何調和鼎鼐、燮理陰陽,整合各方資源以符合GMP規範,即必須將事前工作進行有效協調與檢核,以消除各方專業觀點差異下衍生的工程設計衝突與錯誤,將是該新藥研發企業管理部門責無旁貸的任務;故無論是事前頂層規劃的溝通協調,審慎周延的細部設計必須整合各方應用工法與工序之確認,讓建設施工期間各方團隊得以順利按表操課,於最短的時間內完成GMP認證;即是對於新廠規劃、設計、興建之風險管理目標:「完工延遲」與「成本超支」得以不再發生。據此,本研究規劃建置GMP藥廠建廠之專案管理工具,將可達成以下五項目標:避免設計變更、審慎分工處理、掌握工程品質、落實工程進度、控制成本支出。讓參與建廠專案的各方機構,對於此項建廠專案之認知得以無縫接軌,遇到問題時相濡以沫,共同克服與完成GMP之驗證與確效。
As a biopharmaceutical company obtains a drug permit license for a new therapeutic product, issues surrounding mass production would unquestionably be taken into consideration. During the construction of a new pharmaceutical factory for new products, the quantitative and feasibility analysis are not the only crucial topics anymore facing the increasingly strict and globally promoted GMP regulations. The company, the architect, the architectural and engineering consultant, suppliers of facilities, the construction contractor, subcontractors, etc. each has tasks to conquer to contribute to the goal of meeting the requirements of PIC/S GMP. The management department of the department has to ensure the elimination of errors or disagreements stemming from the difference of perspectives for effective integration of all parties. Coordination or negotiations among executives and inclusive yet detailed design plans have to be achieved beforehand to minimize the time of acquiring a GMP certificate. Allowing all parties to fulfill their duties according to the schedule during construction is the risk management goal of planning, designing, and building a new pharmaceutical factory, to avoid postponing the completion and overrunning the budget. Therefore, through building a project management tool for constructions of pharmaceutical factories under GMP regulations, we aim to prevent design changes, cautiously assign responsibilities, secure construction quality, implement the construction timetable, and assure budgetary control. All parties would hence be able to collaborate on the project, be supportive when problems are encountered, and cooperate to procure the verification and validation of GMP. Finally, the project management tool built in the research would be applied to a simulation assessment of a case in practice.