JOINN Successfully Passed the Japan PMDA Inspection
2021-12-23
JOINN Laboratories (China) Co., LTD and JOINN Laboratories (Suzhou) Inc. successfully passed the online GLP inspection of Japan Pharmaceutical and Medical Devices Agency (PMDA).
Since December 16, 2021, PMDA has carried out online GLP compliance inspection for JOINN (Beijing) and JOINN (Suzhou) (hereinafter referred to JOINN) for a period of one week, in order to support the new drug application of Japanese R&D enterprises. According to relevant laws and regulations, experts of the inspection team carried out a comprehensive and detailed inspection of the organization, operation management, experimental facilities, standard operating procedures, quality assurance system, thematic raw materials, archives and other documents of JOINN.
The inspectors highly recognized the laboratory system and data quality of JOINN. They said that the inspection was the first GLP inspection of non-clinical CRO in China in the history of PMDA in Japan. The inspection went smoothly and they were deeply impressed by JOINN.
