康日百奥Bioworkshops质量体系顺利通过欧盟QP审计

中国，苏州

康日百奥Bioworkshops于2020年11月通过欧洲药品质量受权人对质量体系以及生产场地的审计（简称“QP审计”）。在相继完成两个项目的GMP生产交付、快速获得《药品生产许可证》后，此次通过QP审计，不仅诠释了高质量的“康日百奥速度”，更加彰显公司健全的质量体系能够全面满足EMA、NMPA、FDA药品法规要求。

2020年11月，坐落于中国苏州工业园区的生物药CDMO公司康日百奥生物科技（苏州）有限公司（以下简称“康日百奥”），接受了为期3天的欧洲药品质量受权人（Qualified Person）审计（简称"QP审计"）。本次承担公司QP审计的主审计官来自全球顶尖的法规监管机构ProPharma Group(www.propharmagroup.com)，整个审计参考Eudralex Vol 4（行业内又称为欧盟GMP）法规，评估公司原液和成品生产质量体系的法规符合性。康日百奥成功通过本次审计，标志着有能力为在欧洲市场进行临床试验的客户提供临床产品的生产和分析服务。也表明康日百奥的硬件设施、确认、验证、质量体系搭建及运转完全符合国际制药行业的普遍GMP标准。作为一个刚成立一年多的生物药CDMO公司，顺利通过QP审计，这是“康日百奥速度”的再次诠释，也为公司推进全球商业布局奠定了坚实基础。

由于受到COVID-19疫情影响，本次QP审计由多位审计官以全英语远程方式进行，参与此次审计多位成员的全英文交流使审计官能够全面了解到公司质量管理体系的建设和运营。康日百奥所有的书面程序均以双语书写，既满足国际的申报要求，也为审计顺利开展添砖加瓦。依照EU Eudralex Vol 4的适用章节和附录（欧盟GMP），以及ICH的指导原则，审计覆盖了整个工厂从细胞库构建到注射液制造的所有GMP活动。 

康日百奥自2020年5月建立完成可以容纳6x2000L的生产设施后，已经相继高质量交付了2个项目的多批次500L及200LGMP原液和成品的生产，用于客户IND申报。康日百奥致力于为全球合作伙伴提供高效、经济的生物制药外包服务解决方案。团队成员在生物药领域积累多年的经验为公司质量体系有效地运营提供了扎实的基础。

最后，康日百奥首席执行官邝志威博士向审计官对公司质量体系的认可和连续3天的辛苦工作表示了感谢, ”此次在短时间内通过欧盟QP审计，再一次证明了我们一贯以质量高标准和效率高要求服务全球客户。质量始终是为客户服务过程中贯穿的主线，感谢客户对康日百奥的选择与支持，以及在项目配合中不断的认可。同时也感谢我们团队在这一年内的辛勤付出，有了我们在药物开发领域多年经验加持，康日百奥将继续作为生物药行业发展的’新引擎’不断助力生物药研发生产的快速发展。将客户委托的项目做快，做好，做优。“ 

关于康日百奥生物科技(苏州)有限公司：

康日百奥生物科技(苏州)有限公司是一家专业的生物制药CDMO。成立于2019年初，公司服务范围包括细胞株开发、原液和制剂工艺开发、分析方法开发，制剂处方开发以及原液和成品的cGMP生产。团队成员均为经验丰富的生物制药行业资深人士，对生物药CMC领域有着深刻的理解。他们在业界领先的生物制药研发和生产企业所积累的丰富经验是康日百奥得以快速建立并为客户提供优质服务的关键。

康日百奥致力于为全球合作伙伴提供高效、经济的生物制药外包服务解决方案，帮助合作伙伴缩短药物进入临床试验和上市的时间，同时有效降低药物的开发和生产成本。

Bioworkshops successfully passed EU QP audit

SUZHOU，China

In November 2020, Bioworkshops passed a European drug Qualified Person audit (QP audit) for manufacture of clinical drug substance and drug product at their Suzhou site.  The ratification of compliance to EU GMP comes within a month of obtaining a Drug Manufacturing License from the NMPA and completing the GMP manufacture and delivery of two projects. These achievements demonstrate the company’s quality system can fully meet EMA, NMPA, and FDA drug regulatory requirements and are a great example of high quality “Bioworkshops speed”.

In November 2020, Bioworkshops, a professional biopharmaceutical CDMO located in Suzhou Industrial Park, China, completed a three-day audit to assess its capabilities and infrastructure to adhere to European Commission Guidelines to Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use (“QP Audit”). The audit was conducted by the international, independent regulatory and compliance agency ProPharma Group (www.propharmagroup.com) and evaluated both drug substance and finished product manufacturing for compliance to EudraLex Volume 4 European Union Guidelines (EU GMP). Bioworkshops successfully passed the audit for clinical production, validating that it has the capability to provide production and analytical services to customers that intend to conduct clinical trials within Europe. It also shows that Bioworkshops hardware facilities, quality system, and operations comply with the general GMP standards of the international pharmaceutical industry. As a biologics CDMO established just over a year ago, it is another great example of "Bioworkshops Speed", laying a solid foundation for growth into the global stage. 

With COVID-19 travel restrictions prevailing, the audit was conducted remotely in English. At Bioworkshops all GMP procedures are bilingual for ease of audit by international agencies. The live online audit provided the auditors thorough understanding of Bioworkshops facilities and operation of the quality management system. The scope of the audit covered manufacturing and testing of Drug Substance and Drug Product for compliance with all chapters and all applicable annexes of EudraLex Volume 4 European Union Guidelines and ICH guidelines (EU GMP).

Since the completing construction of the production facility with capability of up to 6×2000L in May 2020, Bioworkshops has successfully completed two client projects with multiple batches at 500L and 200L GMP for drug substances and aseptic products for IND submissions. Bioworkshops is committed to provide efficient and economical biopharmaceutical outsourcing service and solutions for global business partners. The team has massive depth of experience in biopharmaceutical development which provides solid foundation for high-quality operations. 

Dr. Simon Kwong, CEO of Bioworkshops, expressed his gratitude to the auditors for their diligence in assessing the company’s quality standards. “Quality is always at the heart of serving our customers. Passing an EU QP audit within such a short period of time proves that we reliably serve our customers with global quality standards and high efficiency. Thanks to the auditors from ProPharma for their meticulous inspection and our team members for their hard work to establish the systems during this year. A big thanks to our customers for their support and recognition in selecting Bioworkshops. Bioworkshops will continue to be a “new engine” for development of the biopharmaceutical industry and continue to accelerate development of biopharmaceutical R&D and manufacture, serving our clients faster and better.”

About Bioworkshops (Suzhou) Limited

Bioworkshops is a professional biologics contract development and manufacturing service provider committed to offering cost-effective and efficient outsourcing solutions to assist our customers shorten the time to start clinical trials and enter markets. Our services include process development, analytical development and cGMP manufacturing. Our Mission is working with selected global partners to achieve rapid approval of clinical and commercial biologics by applying our expertise in development and manufacturing from a base in China.

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