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绿色制药中的质量管理体系优化与环境合规性研究

Research on the Optimization of Quality Management System and Environmental Compliance in Green Pharmaceuticals

Environment and Resource / 2026,8(1): 66-72 / 2026-02-28 11 5

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• Authors: 刘敏 易旭东 方宝 周光旭
• Information:

  太极集团重庆涪陵制药厂有限公司，重庆

• Keywords:
  Green pharmaceutical manufacturing; Quality management; Environmental compliance; Green design; Sustainable development
  绿色制药; 质量管理; 环境合规性; 绿色设计; 可持续发展
• Abstract: With the global advancement of sustainable development agendas and the “dual carbon” strategic goals, the pharmaceutical industry is facing significant challenges in its green transformation. Green pharmaceutical manufacturing must not only ensure drug quality and safety but also minimize resource consumption and waste emissions during production, thereby promoting the simultaneous enhancement of economic, environmental, and social benefits. This study proposes an integrated framework centered on the concept of “Quality by Green Design”, aiming to deeply integrate environmental compliance with quality management systems. By establishing this framework, environmental requirements are shifted from end-of-pipe treatment to design parameters at the R&D stage, fostering the simultaneous development of both “green” and “high-quality” attributes. This paper analyzes representative case studies from Taiji Group and Pfizer, demonstrating integrated approaches to green pharmaceutical manufacturing and their synergistic benefits. Integrating quality management with environmental compliance can improve production efficiency, reduce costs, mitigate risks, and enhance a company’s social responsibility image. The pharmaceutical industry should intensify efforts in green technology and digital transformation, promoting a shift from supply chain compliance to an ecosystem of value chain symbiosis, thereby advancing the vision of global green pharmaceutical manufacturing. 伴随全球可持续发展议程跟“双碳”战略目标逐步推进，制药行业正面临绿色转型的极大挑战，绿色制药需保证药品的质量跟安全性，还需在生产期间把资源消耗与废物排放降到最低限度，推动经济、环境跟社会效益一起提升，本研究提出的整合框架围绕“质量源于绿色设计”这一理念展开，意在把环境合规性跟质量管理体系深度融合起来。依靠搭建这个框架，环境的需求从末端治理转换为研发开端的设计参数，促进绿色跟高质量“双基因”同步发展，本文对太极集团以及辉瑞公司的典型案例进行剖析，呈现出绿色制药的整合方法及其产生的协同效益。质量管理与环境合规性融合可提升生产效率，降低成本、抵御隐患，构建企业的社会责任形象，制药行业应加大绿色技术及数字化转型力度，推动形成从供应链合规过渡到价值链共生的生态模式，以此实现全球绿色制药的设想。
• DOI: https://doi.org/10.35534/er.0801008 (registering DOI)
• Cite: 刘敏，易旭东，方宝，等．绿色制药中的质量管理体系优化与环境合规性研究［J］．环境与资源，2026，8（1）：66-72.