疫苗是特殊的药品。疫苗产品变更管理作为确保质量管理有效执行的基本要素，其提升方式有助于应用到整个质量体系。对疫苗产品国内变更管理基本要求、世界卫生组织（WHO）预认证对变更控制的总体要求进行分析，并结合企业通过WHO预认证的变更提升实例，探讨疫苗产品企业如何系统性提升变更管理业务能力，对接国际标准。

Vaccines are special drugs, and vaccine product change management is a fundamental element to ensure effective implementation of quality management. Its improvement can be applied to the entire quality system. This article analyzes the basic requirements for domestic vaccine product change management, as well as the overall requirements for change control by the World Health Organization (WHO) prequalification. It analyzes examples of companies' efforts to improve their change management capabilities through WHO prequalification, and explores how vaccine product companies can systematically enhance their change management capabilities and alignment with international standards.

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