本报讯(记者冯雨瑶)12月29日晚间，重庆博腾制药科技股份有限公司(以下简称"博腾股份（300363）") 发布公告称，公司全资子公司重庆博腾药业有限公司(以下简称"博腾药业")于近日获得欧盟质量受权人 (QualifiedPerson，QP)签发的符合性声明，顺利通过欧盟QP审计。 公告显示，本次审计依据EU GMP Guidelines EudraLex Volume4、EUClinicalTrial Regulation(536/2014)及 GMPfor IMP指导原则，审计范围涵盖公司重庆制剂生产基地注射剂、口服固体制剂及非无菌半固体制 剂业务的质量管理、生产管理、厂房设备设施、物料系统、包装与标签系统等方面。 本次顺利通过QP审计，标志着博腾药业的质量管理体系已达到欧盟GMP标准，能够为全球客户提供符 合国际标准的制剂定制研发生产服务。另据公告披露，本次通过欧盟QP审计不会对博腾股份当前业绩 产生重大影响。 ...

格隆汇12月29日丨博腾股份(300363.SZ)公布，全资子公司重庆博腾药业有限公司（简称"博腾药业"）于 近日获得欧盟质量受权人（QualifiedPerson, QP）签发的符合性声明，顺利通过欧盟 QP 审计。本次审 计依据 EU GMP Guidelines EudraLex Volume 4、EUClinical TrialRegulation（536/2014）及 GMP for IMP 指导原则，审计范围涵盖了公司重庆制剂生产基地注射剂、口服固体制剂及非无菌半固体制剂业务的质 量管理、生产管理、厂房设备设施、物料系统、包装与标签系统等方面。本次顺利通过QP审计，标志 着博腾药业质量管理体系已达到欧盟 GMP 标准，能够为全球客户提供符合国际标准的制剂定制研发生 产服务。 ...

Core Viewpoint - The company has successfully passed the EU Quality Person audit, indicating that its subsidiary has met EU GMP standards for quality management and production capabilities [1] Group 1: Audit and Compliance - Chongqing Haoyuan has received a compliance audit report issued by the Qualified Person (QP) after a thorough audit covering quality management, production management, facilities, material systems, and packaging and labeling systems [1] - The audit assessed critical aspects such as sterility assurance, computerized systems, data integrity, quality management, and material management [1] Group 2: Organizational Readiness - Chongqing Haoyuan has established an organizational structure, personnel configuration, facilities, and procedures that comply with EU GMP requirements [1] - The successful QP audit signifies that the company's quality management system and production capacity are aligned with EU GMP standards, ensuring high-quality research and production of biopharmaceuticals [1] Group 3: Market Expansion - The achievement of passing the QP audit lays a foundation for the company to expand into domestic and international markets [1] - The successful audit is not expected to have a significant impact on the company's current performance [1]