Our Performance
Our auxiliary European and American GMP certification project: lizhu Monoclonal Antibody (US cFDA), Beida Unnamed Antibody (Overall Design of Factory Area), Shanxi Nuocheng Pharmaceutical (PIC\S Certification), Zhejiang Jingwei Pharmaceutical (US cGMP), Henan Dongtai Pharmaceutical (EU cGMP), Changchun Baiyi Pharmaceutical (EU cGMP Raw Materials and Preparation Computerized System Verification), Anshi Pharmaceutical (China) (EU and US FDA), Shenzhen CNOOC Haidewei (Factory Overall Verification Project), nanxiong Yangpu Pharmaceuticals (API Brazil GMP certification), Guangzhou Baiyunshan Hanfang Pharmaceuticals (European and American GMP system training), Hangzhou East China Pharmaceuticals, Senti Bio project, etc.
Durst helped the national medicine Zhijun pass the EU GMP certification in April 2022, Sichuan Huiyu Pharmaceutical pass the FDA cGMP certification in August, Anhui Longkema Biology pass the WHO certification in October, and an enterprise in Shenzhen successfully pass the EU GMP inspection for non-final sterilized injections in Germany in November.
In April 2023, it helped Shuode Pharmaceutical to pass FDA cGMP certification, and in August, it helped Shenzhen National Medicine to pass TGA GMP certification.
In September 2023, help Chengdu Shengnuo Biology pass the PAI inspection of FDA cGMP;
In November 2023, Sichuan Huiyu Pharmaceutical was helped to pass the on-site inspection of FDA cGMP. Guangdong Xinghao Pharmaceutical, a customer served by Durst, passed the on-site inspection of FDA cGMP.

The verification projects we have completed in recent years include: lizhu Biological Vaccine Production Line Verification Project (Stock Solution Preparation), Shenzhen Yinuo Micro Pharmaceutical Technology Aseptic Production Line Verification Project, Zhuhai Ruisipuli Workshop Overall Verification Project, Zhuhai Manulife Pharmaceutical Workshop Equipment Verification Project, Hainan Senqi Pharmaceutical Co., Ltd. Workshop Equipment Verification Project, Shenzhen Yinuo Micro Pharmaceutical Technology Aseptic Production Line Re-verification Project, Zhuhai Manulife Pharmaceutical Workshop Equipment Re-verification Project, Longsha Biological Equipment Verification Project, Baiji Biological Equipment Verification Project project, Agner Plant Verification Project, Sichuan First Medical Technology Plant Overall Verification Project.
In terms of computerized system verification (CSV), we have completed a number of CSV verification projects in recent years in pharmaceutical integrated systems, network workstation systems and scientific data management systems, and various stand-alone workstation software in laboratories. We have successively completed computerized system verification services for equipment and systems for customers such as Lizhu Biology, CR Jiuxin Pharmaceutical, Zhuhai Risipu, Corning Jerry, Lianxin Pharmaceutical, Shanghai Danrui Biology, North China Pharmaceutical, etc.