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质量风险管理在制药领域的应用与环境可持续性研究

The Application of Quality Risk Management in the Pharmaceutical Industry and Research on Environmental Sustainability

Environment and Resource / 2025,7(2): 304-310 / 2025-12-30 10 7

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

  太极集团重庆涪陵制药厂有限公司，重庆

• Keywords:
  Quality risk management (QRM); Pharmaceutical industry; Environmental sustainability; Integrated risk governance
  质量风险管理; 制药行业; 环境可持续性; 综合风险治理
• Abstract: While safeguarding public health, the pharmaceutical industry exerts sustained pressure on the environment due to its high energy consumption, high material consumption, and high emissions. Based on a review of Quality Risk Management (QRM) theories such as ICH Q9, this paper integrates environmental sustainability into the QRM framework and proposes an approach for quality-environment integrated risk governance. Focusing on key stages such as R&D and process design, production operations, and supply chain management, it examines how green processes, energy efficiency improvements, and resource recycling can reduce environmental burdens while enhancing process stability and drug quality. Through case studies of domestic and international enterprises and regulatory practices, the paper reveals the coupling relationship between inadequate quality culture and the accumulation of environmental risks, while also identifying current bottlenecks in data integration, multi-objective trade-offs, and supply chain collaboration. The article recommends building a quality-environment integrated risk management system, promoting the development of digital platforms and comprehensive performance evaluation, strengthening green supply chain collaboration, and cultivating interdisciplinary talent. It concludes that deeply embedding environmental objectives into QRM is a critical pathway for pharmaceutical enterprises to achieve high-quality and green, low-carbon development. 制药行业在守护公共健康的同时，凭借高能耗、高物耗和高排放，对环境形成持续压力。本文在对ICHQ9等质量风险管理（QRM）相关理论进行梳理的基础上，将环境可持续性融入QRM框架，提出质量-环境综合风险治理思路，以研发与工艺设计、生产运营及供应链管理等环节为核心，研究绿色工艺、能效增进和资源循环利用如何在降低环境负荷的同时提升工艺稳定性和药品质量。依托国内外企业与监管的相关案例，揭示质量文化薄弱与环境风险积聚的耦合关系，同时指出当下在数据整合、多目标权衡以及供应链协同方面的主要梗阻。文章建议构建质量—环境一体化风险管理体系、推动数字化平台及综合绩效评价发展、强化绿色供应链协同和复合人才培养，表明将环境目标深度嵌入QRM是制药企业实现高质量及绿色低碳发展的重要手段。
• DOI: https://doi.org/10.35534/er.0702025 (registering DOI)
• Cite: 易旭东，刘敏，周光旭，等．质量风险管理在制药领域的应用与环境可持续性研究［J］．环境与资源，2025，7（2）：304-310.