近日，博沃生物重组腺病毒载体疫苗原液及成品生产现场顺利通过欧盟质量授权人（Qualified Person, QP）审计，获得由QP核准签发的GMP符合性证明。
在本次欧盟QP审计中，欧盟审计官依据Eudralex Vol 4法规（欧盟药品质量管理规范）及其附录、人用临床试验样品法规(EU) 536/2014、国际人用药品注册技术协调会（ICH）等指导原则，对武汉博沃重组腺病毒载体疫苗原液及成品生产现场（含QC实验室），涵盖质量管理体系、厂房设施设备管理系统、人员培训系统、验证和计算机化系统、文件管理系统、物料管理系统、质量控制和放行管理系统等方面进行了全面系统的GMP核查。审计过程中，审计官对现场和文件进行了全面细致的核查，提出了大量专业性、建设性的反馈和意见。武汉博沃迎检团队对审计官的提问一一作了详尽解答。审计官对武汉博沃生产厂房、质量管理体系、专业团队给与了高度评价，博沃生物CEO吴克博士对审计官提出的宝贵意见表达了由衷感谢。
此次顺利通过欧盟QP审计，标志着博沃生物临床试验样品生产现场和质量管理体系已符合欧盟GMP标准，是公司全球化布局的又一里程碑式进展。未来，公司将持续推进质量管理体系建设，为重磅管线产品的合规试生产和临床研究开展提供有力可靠的保障，也为各产品管线推进到国际标准商业化生产奠定了基础。
Recently, BravoVax successfully passed the remote audit of the EU Qualified Person (QP) for its manufacturing site of bulk and finished product of recombinant adenovirus vector vaccine, and officially secured QP declaration.
According to the Eudralex Vol 4 (EU GMP) and its annexes, the Clinical Trials Regulation (EU) No 536/2014, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and other guidelines, the auditors have completed a comprehensive and systematic GMP inspections on BravoVax’s manufacturing site (including QC laboratories) of bulk and finished product of recombinant adenovirus vector vaccine, covering quality management system, premises and facilities management system, personnel training system, validation and computerized system, documentation system, material management system, quality control and release management system, etc. During the audit, the auditors gave a good number of professional and constructive feedback and comments. Detailed answers were given by BravoVax’s auditee team to every of the questions that raised. At the end of the audit, the auditors expressed high recognition of BravoVax’s manufacturing site, quality management system and its professional team. Dr. Wu Ke, the CEO of BravoVax, expressed his sincere appreciation to the auditors for their meticulous working and valuable opinions.
The securing of EU QP’s declaration not only marks that BravoVax’s manufacturing site and quality management system comply with EU GMP standards, but it is also an important milestone for the company’s layout in global market. BravoVax will continuously optimize its quality management system, providing a strong and reliable guarantee for the GMP-compliant pilot production and clinical study of its blockbuster products, as well as building a solid foundation for promoting the commercial manufacturing of each product as per international standards.
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上海博沃生物科技有限公司（简称博沃生物）2011年3月成立于上海张江高科技园区，2021年10月迁至北上海生物医药园。2012年12月设立了武汉博沃，是国家级高新技术企业、中国疫苗行业协会理事单位。2020年公司被德勤Deloitte评为“中国明日之星”，是内地唯一获奖的生物医药企业。公司具有基因编辑/构建/克隆/检测、细菌大规模培养、细胞/病毒大规模培养、生物活性物质制备（多糖、蛋白质、病毒等）、多糖与蛋白质化学结合、新型佐剂、新型制剂、新型检测等多个先进技术平台，满足各类创新型生物医药特别是疫苗开发的需要。博沃生物以满足中国和世界人民健康生活的美好愿景为己任，致力于通过重磅级创新疫苗的开发和市场化运营，成为全球疾病控制领域的主力军。
Shanghai BravoBio Co., Ltd (BravoBio) was established in Zhangjiang Hi-Tech Park in Shanghai in March 2011 and moved to MediPark in North Shanghai in October 2021. Its subsidiary company, Wuhan BravoVax Co., Ltd (BravoVax), was founded in December 2012. BravoVax is a "state level high-tech enterprise" and a council member of China Association of Vaccines (CAV). It was awarded as "China Rising Star" by Deloitte in 2020, becoming the only biopharmaceutical enterprise in Chinese mainland to win this award. The company boasts a number of advanced technology platforms, including gene editing / construction / cloning / detection, large-scale bacterial / cell / virus culture, preparation of bioactive substances (polysaccharide, protein, virus, etc.), chemical combination of polysaccharide and protein, novel adjuvant, new preparation and analytical assays, etc. to meet the needs of developing innovative biologics, especially vaccines. BravoBio has held the mission to improve the quality of people's lives, aiming for a healthier and happier future. The company is active to be a global supplier of high-quality vaccine through development and commercialization of its innovative and blockbuster vaccines, contributing to the control of global diseases.
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