通过 GMP 的实施，逐步淘汰了无法达到质量标准的制药企业。通过 GMP 认证
的制药企业,也借此机会提升了自身的质量管理水平，药品质量得到了进一步保
障
B 公司专注于无菌制剂的生产，是首批通过 GMP 认证的企业。企业在持续
的发展中，一些生产过程中的问题开始出现，使得公司的投诉率上升，产品成本
升高。本文对于 B 公司在生产过程中出现的质量管理问题进行关注。本文在第
一章首先对 B 公司进行了简单的介绍，对本文需要研究的内容进行了描述。第
二章介绍了生产过程持续改进理论中与本文相关的部分，以及制药企业自身质量
管理规范。第三章用于描述 B 公司现行生产过程中存在的一些问题。介绍了公
司产品的特性以及生产过程监控措施，并对质量重点工序生产过程中出现的质量
问题进行描述。第四章从人、机、料、法、环这几方面入手，对生产过程进行分
析和实施改进措施。针对第三章中描述的问题，第五章描述了制袋工序的质量改
进过程。在一次偏差调查，运用统计学工具对问题进行了深入分析并制定了质量
改善对策。第六章叙述了灌装工序的过程监控改善。同样是运用统计学工具，更
精确的把握生产过程。最后一章阐述了包装工序过程的改进措施。强化包装目检
的有效性，增加目检结果对过程改进的指向性。上述措施都有助于提升生产过程
的质量控制水平
本文的研究内容对于制药企业的生产过程质量改进具有一定的参考价值
关键词：生产过程质量改进,质量管理,持续改进II
ABSTRACT
The quality of the drug has a key impact on the health of the patients and
development for the pharmaceutical enterprises. The drug quality crisis has led the
government, the public and the pharmaceutical companies to pay special attention to
the quality of drug production. China promulgated its Good Manufacturing
Practices (GMP) according to foreign advanced concept of pharmaceutical
management. By the implementation of GMP, the pharmaceutical companies which
failed to meet the quality standards have been eliminated. The companies which
passed the GMP certification have taken the opportunity to enhance their quality
management level and the drug quality has been guaranteed.
Company B，which focuses on the production of sterile drug, is one of the first
batch enterprises through the GMP certification. With the development of enterprises,
some problems in the production process begin to emerge, making the company&39;s
complaints rate and the cost of products increased. This thesis focuses on the quality
management problems in the process of production. In the first chapter, this thesis
makes a brief introduction of B Company, and then described the content of this
thesis. The second chapter introduces the theory of continuous improvement of
production process which will quote in this thesis, as well as the quality management
of pharmaceutical enterprises. The third chapter describes some problems existing in
the current production process of B Company. This part introduces the characteristics
of the company&39;s products and the monitoring measures of the production process and
described the quality problems in the Key working procedure. In the fourth chapter,
the production process is analyzed and the improvement measures are implemented
from human, machine, material, method and environment. Aiming at the problem
described in the third chapter, the fifth chapter describes the quality improvement of
bag making process. In a survey of deviation, the problem is analyzed and the quality
improvement measures are established by using statistical tools. In the sixth chapter,
the process monitoring and improvement of filling process is described. The
production process will be grasped more accurate by using statistical tools. In the last
chapter, the improvement measures of packaging process are described. The
effectiveness of packing inspection will strengthen and the directivity of the process
improvement will be increased. All of the above measures are helpful to improve theIII
quality control level of the production process.
The research content of this thesis has a certain reference value for the quality
improvement of the manufacturing process of pharmaceutical enterprises.
KEY WORDS: Continuous improvement, Quality management, Process quality
improvementI
目录
中文摘要 ........... I
ABSTRACT..... II
第 1 章 问题的提出 .....1
1.1 B 公司简介 .......1
1.2 研究内容及意义 ...........1
第 2 章 制药企业生产过程质量改进理论综述.........3
2.1 持续改进对质量管理的作用 .....3
2.1.1 产品质量对于企业的重要性...........3
2.1.2 产品质量的持续改进...........4
2.2 制药企业的生产过程质量改进 .4
2.2.1 药品生产质量管理规范（GMP）..4
2.2.2 偏差管理.......5
2.2.3 借鉴其它行业先进的过程质量改进方法...5
第 3 章 B 公司生产过程存在的质量问题......7
3.1 B 公司产品特性及生产过程关注点 ......7
3.2 B 公司现行过程监控措施及生产过程简述 ......7
3.2.1 制袋工序生产过程存在的质量问题...........8
3.2.2 灌装工序生产过程存在的质量问题...........8
3.2.3 包装工序生产过程存在的质量问题.........10
第 4 章 B 公司生产过程 5M1E 分析与改进...........11
4.1 B 公司质量文化的确立和宣传11
4.2 B 公司生产过程中质量影响因素的控制 ........ 11
4.2.1 人员..12
4.2.2 设备..13
4.2.3 物料..19
4.2.4 法规..20
4.2.5 环境..23
4.3 结论....23
第 5 章 质量工具在制袋工序偏差调查中的应用...25
5.1 制袋工序质量控制问题分析 ...25II
5.2 质量工具在偏差调查中的应用 ...........25
5.3 结论 .......40
第 6 章 灌装工序过程管理的改进...41
6.1 灌装工序质量控制问题分析 ........
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