WHO技术报告系列（Technical Report Series, TRS）为生物医药行业提供了重要的技术指南，涵盖了从产品研发、临床试验到商业化生产、分销运输以及退市全生命周期的技术规范和标准，指导企业建立全面的知识体系，确保其产品符合国际标准。此文介绍了WHO TRS 的来源、编号原则、对生物医药行业的指导意义和TRS本身面临的挑战，从质量管理、厂房与设施、质量控制、生产管理、储存与分销以及核查等方面，汇总罗列了相关的TRS，并对各板块作简要介绍；根据多年的质量管理和WHO预认证的实战经验和体会，分享了如何有效学习WHO TRS，以指导企业的全面质量管理工作和加速企业WHO 预认证项目。

WHO Technical Report Series (TRS) provides important guidances for the drug industry, covering technical specifications and standards for the entire life cycle ranging from product research and development, clinical trials to commercial production, distribution and transportation, and discontinuation. It guides enterprises to establish a comprehensive knowledge system to ensure their products meet international standards. This paper introduces the source and numbering principle of WHO TRS, its guiding significance for the medical product industry, and the challenges faced by TRS. The WHO TRS is listed and introduced, which is divided into quality management, premises and facilities, quality control, production management, storage and distribution, and inspection. Based on years of practical experience and insights in quality management and WHO prequalification by the authors, this article shows how to effectively use WHO TRS to guide enterprises through comprehensive quality management work and acceleration of WHO prequalification projects.