企业竞争的实质，归根结底是产品质量的竞争，提升产品质量，是确保市场 占有率，进而保持持续经营的关键所在。药品质量水平不仅与企业自身的技术水 平有关，而且与企业的质量管理水平有关。对于制药行业的公司而言，如何确保 药品质量在于建立质量管理的战略地位。质量管理水平在其市场竞争中的必要性 不言而喻。 这篇论文的研究对象为QL制药公司，选择该公司的原因主要是因为本人非 常熟悉公司的生产质量管理情况。QL制药公司质量管理的依据就是新版本的药 品生产质量管理规范（Good Manufacturing Practice, GMP缩写）。本文运用问卷 调查、访谈提纲、文献比对等研究方法，对QL制药公司质量管理方面的问题进 行阐述，讲解了制药行业里质量管理方面的理论知识，针对质量管理中难点问题 加以思考分析，如偏差、变更、供应商评估、验证体系等问题，找出 QL 制药 公司药品质量管理问题的根本原因，并且分析研究这些原因，例如研究分析偏差 的管理、变更的控制、供应商的审计及管理、验证体系管理等等，彻底解决本公 司药品质量管理系统方面的问题，得出本文的研究结论：完善偏差管理、改善变 更控制、优化供应商评估和完善质量验证体系。 观察山东省所有的医药生产企业，QL制药公司绝对是一家大中型药品生产 企业，在企业不断发展的历程中，特别是在药品的整个生命周期中，都需要严格 把控产品的质量。本公司在质量管理过程中遇到了众多问题，本篇论文主要研究 的是一些有很强代表性的问题，针对这些问题提出解决问题的方案。其他企业质 量管理过程中遇到困难时，可以借鉴解决思路，并给与启示。对于质量管理来说， 需要全体员工的积极参与并持之以恒，在持续完善改进的过程中，就要不断引进 先进管理理念优化完善质量管理，企业发展离不开质量。公司的质量水平达到一 定的高度，才能认真履行社会责任，更好的实现对患者的承诺。 关键词 药品，生产质量管理规范，质量管理 山东师范大学硕士学位论文 Abstract The essence of enterprise competition is the competition of product quality in the final analysis. Improving product quality is the key to ensuring market share and maintaining sustainable operation. The quality level of pharmaceuticals is not only related to the technical level of the enterprise itself, but also to the quality management level of the enterprise. For pharmaceutical enterprises, how to ensure the quality of medicine lies in establishing the strategic position of quality management. The necessity of quality management level in its market competition is self-evident. The research object of this thesis is QL pharmaceutical company. The reason why I choose this company is that I am familiar with the production quality management of the company. The basis of QL pharmaceutical company’s quality management system is the new version of Good Manufacturing Practice (GMP abbreviation). This thesis uses questionnaire survey, interview outline, literature comparison and other research methods. It addresses the quality management aspects of QL pharmaceutical company. This thesis describes some theories of quality management in pharmaceutical industry. This thesis analyzes the difficult problems in its quality management system, such as deviation, change, supplier evaluation, validation system and so on. It finds out the root cause of the problem of QL Pharmaceutical Company’s drug quality management system. This thesis also analyzes its causes, such as deviation management problem analysis, change management problem analysis, supplier management problem analysis, validation system problem analysis, etc. It finds out the solution to the problem of QL Pharmaceutical Company’s drug quality management system. In the end the research conclusions of this thesis are as follows: improve deviation management, improve change control, optimize supplier evaluation and improve quality validation system. Observing all pharmaceutical manufacturers in Shandong Province, QL Pharmaceuticals is definitely a large pharmaceutical manufacturer. It is in the course 山东师范大学硕士学位论文 of continuous development of the company .Especially in the whole life cycle of medicines, companies need to strictly control the quality of products. The company encountered many problems in the quality management process. The company uses some highly representative issues for topic research. It analyzes and proposes solutions to problems. When encountering difficulties in the quality management process of other enterprises, they can learn from the solutions and give inspiration. Constant optimization and continuous improvement of the quality management system requires the participation of all staff and long-term persistence. In this process, It is necessary to continuously introduce advanced management concepts to optimize and improve the quality system. Enterprise development is inseparable from the quality system. The quality level of the company reaches a certain height. Only then can companies fulfill their social responsibilities seriously. Companies are better able to deliver on their promises to patients. Key words: Drug ; Good Manufacturing Practice ; Quality Management 山东师范大学硕士学位论文 目 录 第1章 绪论 ....................................................... 1 1.1研究背景和意义............................................... 1 1.1.1研究的背景 ............................................. 1 1.1.2研究的意义 ............................................. 2 1.2国内外研究现状............................................... 3 1.2.1国外研究现状 ........................................... 3 1.2.2国内研究现状 ........................................... 5 1.3研究的主要内容和方法......................................... 7 1.3.1研究内容 ............................................... 7 1.3.2研究方法 ............................................... 7 1.4研究的思路和框架............................................. 8 1.5论文主要创新................................................ 10 第2章 相关理论基础 .............................................. 11 2.1质量管理基本理论............................................ 11 2.1.1质量管理的发展过程 .................................... 11 2.1.2全面质量管理的标准化 .................................. 13 2.2药品质量管理基本理论........................................ 14 2.2.1药品质量管理的发展过程 ................................ 14 2.2.2药品质量管理的相关理论 ................................ 15 第3章 QL制药公司药品质量管理现状及问题分析 ....................... 18 3.1 QL 制药公司基本情况简介 .................................... 18 3.2 QL 制药公司药品质量管理现状 ................................ 19 3.3调查方法.................................................... 21 山东师范大学硕士学位论文 3.3.1调查问卷、访谈提纲的设计和实施 ........................ 21 3.3.2调查结果分析 .......................................... 22 3.4 QL 制药公司药品质量管理问题 ................................ 25 3.4.1变更管理问题 .......................................... 25 3.4.2偏差管理问题 .......................................... 28 3.4.3供应商管理问题 ........................................ 32 3.4.4质量验证问题 .......................................... 36 3.5 QL制药公司药品质量管理问题原因分析......................... 41 3.5.1变更管理问题原因分析 .................................. 41 3.5.2 偏差管理问题原因分析.................................. 42 3.5.3 供应商管理问题原因分析................................ 43 3.5.4 验证体系问题原因分析.................................. 44 第4章 QL制药公司药品质量管理优化 ................................. 45 4.1变更管理的改善.............................................. 46 4.1.1改变追踪方式并规定变更关闭效期 ........................ 47 4.1.2优化产品稳定性跟踪流程 ................................ 47 4.1.3新建变更行动方案进行工作确认 .......................... 49 4.1.4实行变更管理系统 ...................................... 49 4.2完善偏差管理................................................ 53 4.2.1利用调查工具彻底调查 .................................. 53 4.2.2降低人员因素偏差 ...................................... 56 4.2.3优化偏差的影响评估 .................................... 58 4.2.4明确偏差的纠正行动、纠正措施及预防措施 ................ 60 4.3优化供应商评估.............................................. 61 山东师范大学硕士学位论文 4.3.1依据供应商风险评估结论制定审计频率 ....