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面向绿色制造的制药企业数字化质量管理模式研究

Research on Digital Quality Management Model for Pharmaceutical Enterprises Oriented to Green Manufacturing

易旭东, 张桂, 刘敏

Environment and Resource / 2026,8(2): 245-250 / 2026-06-25 11 8

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• Information:

  太极集团重庆涪陵制药厂有限公司，重庆
  

• Keywords:
  Green manufacturing; Pharmaceutical enterprises; Digital quality management; Quality risk management; Governance model
  绿色制造; 制药企业; 数字化质量管理; 质量风险管理; 治理模式
• Abstract: Against the backdrop of green manufacturing, digital transformation, and high-quality development in the pharmaceutical industry, the traditional quality management model of pharmaceutical enterprises can no longer meet the demands from compliance control to collaborative governance. Although a relatively complete quality management system has been established, there are still deficiencies in the implementation process, such as scattered goals, information silos, lagging risk response, and inadequate departmental collaboration, which prevent it from integrating well with green and digital development. Based on the theories of the pharmaceutical quality system, quality risk management, and dynamic capabilities, this paper designs a digital quality management model that includes data perception, system integration, risk early warning, process closed-loop, and collaborative improvement. It also proposes corresponding implementation methods from aspects such as strategic planning, process reengineering, data management, cross-departmental cooperation, performance linkage, and talent support. The paper discusses the reshaping of quality management goals and the transformation of management methods for pharmaceutical enterprises under the background of green manufacturing, and explores the digital quality management model for pharmaceutical enterprises oriented towards green manufacturing. The research finds that the key to digital quality management in pharmaceutical enterprises is not the superimposition of technologies, but rather breaking down information transmission barriers, reengineering work processes, transforming the quality governance model from post-event handling to pre-event early warning, from experience-based judgment to evidence-based decision-making, and from departmental isolation to overall coordination, thereby achieving an overall improvement in quality levels, environmental quality, and organizational efficiency. 在绿色制造、数字化转型以及医药工业高质量发展的时代背景下，传统药企的质量管理模式已经无法满足从合规管控到协同治理的需求。虽然目前质量管理工作已经形成了较为完善的体系，但是其在执行过程中还存在着目标分散、信息孤岛、风险滞后、部门协作不到位等缺陷，不能很好地与绿色化和数字化相融合发展。本文基于药品质量体系、质量风险管理和动态能力理论，设计了包含数据感知、系统集成、风险预警、流程闭环、协同改进在内的数字化质量管理模式，并从战略规划、流程再造、数据管理、跨部门合作、绩效挂钩以及人才支撑等方面提出了相应的实施方法，对绿色制造背景下药企质量管理目标重塑以及方式转变进行了探讨，研究发现药企数字化质量管理的关键不是技术的叠加使用，而是通过打通信息传递壁垒，再造工作流程，使质量治理模式由事后处理变为事先预警、由经验判断变为证据说话、由部门分割变成整体联动，从而达到质量水平、环境质量、组织效率等方面的整体提高。
• DOI: 10.35534/er.0802033 (registering DOI)
• Cite: 易旭东，张桂，刘敏．面向绿色制造的制药企业数字化质量管理模式研究［J］．环境与资源，2026，8（2）：245-250.