随着我国食品药品监督管理局对药品质量越来越高的要求及人民对用药 安全的诉求，药品生产质量的提高对于所有制药企业来说是永久的追求。在 我国一些排在行业头部的大型药企纷纷试水欧盟 GMP 认证和美国 FDA 认 证，欲达到发达国家的药品生产质量标准，将药品质量控制能力达到行业领 先水平，从而提高企业竞争力，获得进入国际市场的通行证。生产不同的药 品剂型对质量控制能力的要求也不同，其中无菌冻干粉针注射剂是对质量控 制能力要求最高的品种，以这种剂型通过欧盟 GMP 或美国 FDA 认证的药企 在国内寥寥无几。 Y 制药企业是中国制药工业 100 强企业之一，A 股主板上市公司，2014 年开始着手准备以无菌冻干粉针注射剂通过欧盟 GMP 认证,后来又成立了欧 盟认证项目组，经过了 4 年多的时间，项目进展未达预期。经过对项目组成 员的问卷调查和沟通，笔者得出的结论，项目进展遇到的障碍表面上是项目 组技术人员的质量控制知识水平有限，提出的解决方案始终无法满足欧盟 GMP 的标准，但其根本原因在于项目组组织形态上。 笔者以彼得·圣吉的《第五项修炼》为理论基础，对欧盟认证项目组进行 学习型组织建设研究。从构建共同愿景、团队学习、心智模式、自我超越、 系统思考这五个方面进行组织文化建设；从组织扁平化、学习资源平台搭建、 学习机制、绩效考核与激励制度等方面构建保障措施。 本文根据欧盟认证现存问题的实际情况为为依据，通过组织变革的方式 来解决技术上的问题。通过学习型组织制度与文化的构建驱动每位成员有动 力、有方向、有资源进行自我学习，通过知识分享机制达到团队学习的目标， 从而提升团队整体技术水平。 关键词：学习型组织；第五项修炼；欧盟 GMP；制药企业哈尔滨工业大学工商管理硕士学位论文 - II - Abstract With the increasing requirements of CFDA on drug quality and people's demand for drug safety, the improvement of drug production quality is a permanent pursuit for all pharmaceutical enterprises.In China, some large pharmaceutical companies ranked at the top of the industry have been trying for the EU GMP certification and the US FDA certification to meet the drug quality criteria of developed countries, to make the drug quality control ability reaching the leading level of the industry, to improve the competitiveness of enterprises and to enter the international market.The requirements on quality control ability are different for different drug dosage forms, among which sterile freeze-dried powder injection is the most demanding for quality control ability. In domestic only a few of enterprises obtained EU GMP on sterile freeze-dried powder injection. Y pharmaceutical company is one of the top 100 pharmaceutical industry companies in China, listed on the A-share main board market. In 2014, it began to prepare the EU GMP certification on sterile freeze-dried powder injection and established the EU certification project team. Four years later, the project progress didn’t meet the expectation. After the questionnaire survey and interview of the project team members, the author concluded that the obstacles encountered in the project progress were ostensibly the project team members’ limited knowledge of quality control, and the proposed solution was always unable to meet the EU GMP criteria, but the root cause was the organization form of project team. Based on the theory of The Fifth Discipline by Peter·Senge, the author conducts a research on building learning organization for EU project team. The organization culture development is carried out from five aspects, building the common vision, team learning, mental model, self-transcendence and systematic thinking. Construct the supporting measures from the aspects of horizontal organizational structure, learning resource platform building, learning mechanism, performance appraisal and incentive system, etc. In this paper, based on the actual situation of the existing problems of EU哈尔滨工业大学工商管理硕士学位论文 - III - project team, technical problems are solved by means of organizational reform. Through the two-wheel drive of system and culture of learning organizaiton, each member has the motivation, direction and resources to make self-learning. Through the knowledge sharing mechanism achieves the goal of team learning, and improves the technical level of the team. Keywords: learning organization, the fifth discipline, EU GMP, Pharmaceutical company哈尔滨工业大学工商管理硕士学位论文 - IV - 目 录 摘要...............................................................................................................................I Abstract..........................................................................................................................II 第 1 章 绪论................................................................................................................... 1 1.1 课题来源及研究的背景和意义........................................................................1 1.1.1 课题研究的背景..........................................................................................1 1.1.2 课题研究的意义..........................................................................................2 1.2 国内外在该方向的研究现状及分析...............................................................3 1.2.1 国外研究现状..............................................................................................3 1.2.2 国内研究现状..............................................................................................4 1.2.3 国内外文献综述的简析.............................................................................8 1.3 研究内容与方法.................................................................................................9 1.3.1 研究思路.......................................................................................................9 1.3.2 研究内容.......................................................................................................9 1.3.3 研究方法.....................................................................................................10 第 2 章 欧盟认证项目组现存问题及原因分析.....................................................11 2.1 Y 制药企业介绍................................................................................................11 2.2 欧盟认证项目背景及项目介绍......................................................................11 2.2.1 项目背景.....................................................................................................11 2.2.2 项目介绍.....................................................................................................11 2.2.3 项目组组织架构........................................................................................13 2.2.4 项目组各部门职责介绍...........................................................................15 2.3 欧盟认证项目组现存问题分析..................................................................... 16 2.3.1 项目运营情况............................................................................................16 2.3.2 员工缺乏欧盟认证相关知识和经验..................................................... 17 2.3.3 员工缺少学习途径和学习方法..............................................................18 2.3.4 领导管理方式缺乏深思熟虑.................................................................. 18 2.3.5 项目组薪酬制度缺乏激励性.................................................................. 19 2.4 欧盟认证项目组现存问题原因分析.............................................................19 2.4.1 调查问卷及调查过程设计.......................................................................19 2.4.2 原因分析.....................................................................................................20哈尔滨工业大学工商管理硕士学位论文 - V - 2.5 本章小结............................................................................................................33 第 3 章 欧盟认证项目组学习型组织建设..............................................................34 3.1 学习型组织建设思路.......................................................................................34 3.2 欧盟认证项目组学习型组织建设方案........................................................ 35 3.2.1 第五项修炼学习型组织概念推广.................................