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论文编号：	8084
作者编号：	2120132963
上传时间：	2015/12/18 8:49:58
中文题目：	S药业工程项目质量管理研究——以B滴眼剂项目为例
英文题目：	Research on Quality Management of Engineering Project in S Pharmaceutical Company——B Eye Drops Project as an example
指导老师：	石鉴
中文关键字：	制药工程项目，项目质量管理，滴眼剂，验证管理
英文关键字：	Pharmaceutical Engineering Project, Project Quality Management,Eye Drops, Validation Management
中文摘要：	制药工程项目建设涉及咨询策划、工程设计、采购供应、施工安装、试车验收等诸多环节，项目的交付物是制药设施、系统和设备。这些交付物即要符合通用的工程管理规范和相关法律法规，又要符合制药行业强制执行的GMP规范。制药设施的设计、建造、调试和确认，无论是对于药品生产商、工程专家，还是设备供应商，都是极大的挑战。制剂工程项目质量的好坏，对药物制剂产品的质量至关重要，所以加强对此类工程项目的质量管理有着非常重要的现实意义。本文研究工程项目质量管理在药物制剂工厂建设这一特殊领域内的应用，涉及质量管理、项目管理理论与制药行业的强制规范药业生产质量管理规范GMP，以及良好工程规范GEP的融合。在研究GMP验证管理、GEP项目生命周期管理和通用项目质量管理理论的基础上，结合S药业自身特点，围绕项目质量控制流程中的需求阶段、设计阶段、调试验收阶段，以及验证管理工作等重要环节，总结出以往工程项目中存在的问题，分析造成这些问题的原因后，分别给出了更加科学的管理控制措施。具体措施包括将公司组织结构从传统的职能型结构调整为矩阵型结构，制订出更加科学的项目管理控制流程，规范需求管理、设计审核、验证管理以及验收管理等管理环节。为了保障这些管控措施得以顺利应用，S药业还对部分公司内部管理制度进行了有针对性的调整。最后还介绍了这些完善后的新管理方法在B滴眼剂工程项目中的应用情况。通过对工程项目质量管理的研究，S药业进一步加深了对项目质量管理的全面理解和对制剂工程项目质量管理的认识，找出了本企业项目质量管理工作的不足，进一步完善了本企业的管理体系。期望这些经验能够给行业内其他同类企业提供一些借鉴。
英文摘要：	Pharmaceutical engineering projects involve consulting and planning, engineering design, purchasing and supply, construction and installation, commissioning and acceptance, and so on. The deliverables are pharmaceutical facilities, which should both engineering regulations and GMP compliance. Actions in all stages of pharmaceutical engineering project, including design, construction, startup, qualification and acceptance test of pharmaceutical facilities are significant challenges for all involved parts, including pharmaceutical manufacturers, engineering specialist and equipment suppliers. Quality of pharmaceutical preparation engineering projects has direct impact on pharmaceutical preparation product quality, so strengthening quality management of this kind of projects has important practical significance. This thesis focuses on application of engineering project quality management within the special area of building pharmaceutical preparation plant, which involves merging of quality management and project management theory, as well as Good Manufacture Practice (GMP) of pharmaceutical industry and Good Engineering Practice (GEP). Based on research of GMP qualification, GEP project life cycle management and General project quality management theory, combined with own characteristics, S Pharmaceutical Company Summarized problems in validation management and stages of project quality control process, which includes requirements stage, design stage and acceptance stage. More scientific management control measure was given after analyzing the reason for each problem. These measures include adjusting organizational Structure from traditional functional structure to matrix structure, developing a more scientific project management control process, standardized requirement management, design review, acceptance management and validation management. At last, application of this new management measures in B eye drops engineering project is introduced. Through researching on quality management of engineering project, S Pharmaceutical Company further deepened understanding on project quality management and cognition on quality management of pharmaceutical preparations engineering projects, found out deficiency of project quality management and improved company management system. Hopefully this experience has reference meanings to other pharmaceutical companies.
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