At the beginning of may 2024, DST (DST) customer Jiangsu pu Xin biopharmaceutical co., ltd (hereinafter referred to as "pu Xin bio") obtained the EU GMP conformity declaration issued by the EU quality authorized person (Qualified Person, QP), marking the successful completion of EU QP project cooperation between pu Xin bio and DST!

In this project cooperation, DST (DST) arranged a number of experts and relevant technical experts with rich experience in GMP in Europe and the United States according to the requirements of EU standards to first analyze the gap between the system documents and the site of the new biology. At the same time, it conducted pre-audit training for relevant department personnel of pharmaceutical companies, arranged QP simulation audit, and guided pharmaceutical companies to carry out rectification and optimization according to the QP audit report issued so as to successfully pass the audit.

During the on-site inspection, Durst arranged two experts to accompany the inspection, one was responsible for the on-site translation of the whole process, and the other was responsible for answering some questions in the process.

Spectrum New Bio is also a well-known cell drug CDMO leader in the industry. The company is headquartered in Wuzhong District, Suzhou City, with Suzhou headquarters (10000 ㎡ GMP plant and R & D center), Shenzhen and Shanghai bases, initially forming a national layout of the production base network layout; the North Carolina base in the United States is also under construction, and the global layout is synchronized. The platform has supported a number of partners to successfully incubate a variety of CAR-T, TCR-T, stem cells and other drugs.

In the end, with the efforts of both the DST team and the spectrum new biological team, the QP audit was successfully completed and approved by the QP auditor, and prepared for the further internationalization of the enterprise in the future. According to the European Union Pharmaceutical Regulations Collection Volume 4-EudraLex GMP (EU GMP Parts I, II, III and Appendices 1, 2 and 15), we have comprehensively reviewed the quality system, laboratory facilities design, instruments and equipment, laboratory inspection and testing management, biosafety management, data integrity management and other aspects of spectrum new organisms. spectrum new organisms have high-standard quality management system and facilities and equipment, the team is experienced and meets the regulatory requirements of EU GMP. We believe that the GMP compliance, advanced nature and professionalism of the management team of spectrum new biology can better help China and even the global biomedical innovation achievements transformation and quality and safety assurance."

In recent years, with the continuous development of the MAH system, as well as the continuous improvement of the technological innovation capabilities of pharmaceutical companies and the production and service capabilities of R & D institutions, my country's drug R & D companies have occupied an increasingly important position in the world pharmaceutical industry chain, and to a certain extent Driven the international pharmaceutical market. In this situation, domestic drug research and development enterprises, especially before the launch of new projects, through the QP(QualifiedPerson, quality authorized person) compliance audit to obtain QP compliance statement, but also to prove the enterprise quality management and quality control level of an important part.

With the increasing demand for QP audit consulting business in the consulting market, DST combined its own advantages, deeply studied the QP compliance inspection regulations and discussed with several EU compliance consultants, forming a complete set of QP compliance audit counseling mode, which can provide professional QP compliance audit consulting for domestic pharmaceutical enterprises and drug research and development companies, help enterprises to better, faster and more comprehensive through the QP compliance check, to obtain QP compliance statement.

DST Durst has accumulated rich experience in QP compliance audit consultation. He has successively passed QP audit for Yasheng Pharmaceutical, Chengdu Shengnuo Pharmaceutical, Beijing Kangle Guardian, Guangdong Raffles Pharmaceutical, Liaoning Yisheng Biology, Shenzhen Kangtai Biology, Suzhou Yaoming Biology, Jiangsu Ruike Biology, Chinese Medicine Research Institute, Suzhou Jingyun Starry Sky, Zhejiang Hengyu Biology and other pharmaceutical companies, and finally obtained QP compliance statements, and received a lot of praise from customers.