【摘要】 目的 探讨影响药品委托生产管理能力的因素，以提升企业管理水平与药品质量。方法 通过相关文献和国内颁布的法律法规分析，识别影响管理能力因素类型，围绕5项能力和3个维度因素设计调查问卷，并向药品行业从业人员发放问卷，运用SPSS Statistics 27软件对调研数据（n=343）进行统计分析，以揭示药品委托生产管理能力的影响因素。结果 企业内部因素（文化理念、质量管理文件体系、资源配置）、外部环境因素（法律法规、合作伙伴关系）及技术系统因素（信息管理、生产技术与数据分析）对管理能力有显著正向影响。结论 据此提出优化内部管理、加强外部协同、强化技术支撑等策略，为企业委托生产管理实践提供指导。更多还原

【Abstract】 Objective To explore the influencing factors of pharmaceutical contract production management, with the goal of enhancing enterprise management capabilities and drug quality. Methods To identify the factors affecting management capabilities in pharmaceutical contract production, a survey was conducted with 343 industry professionals. Informed by a literature and policy review, the questionnaire was structured around a novel framework featuring five core capabilities and three influencing dimensions. Data analysis using SPSS Statistics 27 revealed the key drivers and their impacts, providing empirical evidence to improve MAH oversight practices. Results The findings indicate that internal enterprise factors(cultural philosophy, quality management document system, resource allocation), external environmental factors(laws and regulations, partner relationships), and technical system factors(information management, production technology and data analysis) exert significant positive impacts on management capability. Conclusion Based on these results, strategies such as optimizing internal management, strengthening external collaboration, and reinforcing technical support are proposed to provide practical guidance for enterprises engaged in contract production management.更多还原