疫苗派驻检查制度已实施5年多，对保障疫苗安全生产底线、提升企业GMP合规水平成效显著。随着我国深度参与国际药品监管体系（如国际人用药品注册技术协调会、国际药品检查合作计划），现行检查机制在国际接轨和专业能力建设方面需要进一步思考和完善。此文基于上海市疫苗派驻检查“四位一体”协同监管模式的实践和发展，从对标国际化、周密组织实施派驻检查、突出派驻检查重点、优化派驻检查策略等维度进行探讨，旨在构建更科学、高效的疫苗质量监管体系，持续提升监管效能。

Five years after the implementation of vaccine resident inspection system, it has achieved remarkable results in ensuring the bottom line of vaccine safety production and improving the GMP compliance level of enterprises.With China’s deep participation in the international drug regulatory system, such as International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use and Pharmaceutical Inspection Co-operation Scheme, the current inspection mechanism needs further consideration and improvement in terms of international integration and professional capacity building. Based on the practice and development of the “four-in-one” collaborative supervision mode of vaccine resident inspection in Shanghai, this paper discusses the internationalization of benchmarking, careful organization and implementation of resident inspection, highlighting the key points of resident inspection and optimizing resident inspection strategies, aiming at building a more scientific and efficient vaccine quality supervision system and continuously improving the supervision efficiency.