JOINN(Beijing) successfully passed the US FDA GLP inspection
2024-05-22
From May 13 to 21, 2024, JOINN Laboratories (China) Co., Ltd. (hereinafter referred to as JOINN (Beijing)) underwent an on-site GLP inspection conducted by the United States FDA. A team of three esteemed inspectors, Dr. Deborah Greco, Dr. Zhou Chen, and Dr. Mark Seaton, meticulously evaluated JOINN (Beijing)'s organizational structure and personnel, facilities and equipment management, operational procedures and quality management system compliance with GLP regulations. Additionally, they thoroughly reviewed a multitude of toxicity test data sets. Following more than a week of rigorous scrutiny characterized by meticulousness and professionalism, the inspection team unanimously concluded that JOINN (Beijing) fully adheres to the US FDA's GLP specifications in terms of its quality management system implementation while ensuring test integrity and data accuracy. During the concluding summary meeting held on the final day of inspection activities, FDA GLP experts expressed their satisfaction with JOINN (Beijing)'s continuous progress in regulatory compliance since their initial regulatory inspection fifteen years ago; this progress has significantly enhanced trust within the FDA's new drug approval department regarding trial data provided by JOINN (Beijing). The inspectors highly praised both the exceptional quality management system implemented at JOINN (Beijing) as well as its efficient operations; furthermore, they wholeheartedly acknowledged and appreciated JOINN employees' profound understanding of GLP principles along with their adherence to regulations when conducting tests according to these guidelines. This successful outcome signifies that JOINN (Beijing) has successfully passed its third inspection for FDA's GLP certification.
In recent years, JOINN has made significant advancements in the informatization of research management to ensure data integrity. They have incorporated a wide range of new equipment and technologies, as well as established innovative methods to meet the evaluation requirements for complex innovative drugs (such as CGT products). These technological advancements have presented new demands and challenges for quality management. The JOINN team remains up-to-date with current trends and continuously enhances their quality management system and methods to guarantee research excellence. This FDA inspection once again validates their adherence to international norms regarding GLP operation management under the present circumstances.
The successful completion of the FDA GLP inspection for JOINN's two facilities in Beijing and Suzhou marks the fifth consecutive time they have achieved this milestone, showcasing JOINN's exceptional international service capabilities. Moving forward, JOINN remains committed to advancing its operations and delivering compliant and efficient nonclinical assessment services to both domestic and foreign drug research and development institutions, as part of its overarching mission to foster drug innovation.
We extend our heartfelt gratitude to all members of society for their unwavering care and support towards JOINN.
JOINN Laboratories (China) Co., Ltd.
2024.5.22