Construct a Project Management Tool for GMP Pharmaceutical Plant Planning and Construction

• Main Authors: LIN, KUO-CHANG, 林國嵢
• Other Authors: YANG, WEN-HUA
• Format: Others
• Language: zh-TW
• Published: 2019
• Online Access: http://ndltd.ncl.edu.tw/handle/28794m

碩士 === 朝陽科技大學 === 企業管理系高階產業經營碩士在職專班 === 107 === 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.