JOINN Laboratories Passed US FDA GLP Re-inspection
2013-09-28
From September 16th to September 20th, 2013, JOINN Laboratories (Beijing) received and successfully passed US FDA GLP re-inspection. The three-man inspection team inspected experimental facilities, equipment, staff, SOPs, documentations and experimental implementation, and have chosen several submitted studies for detailed traceability check. With many years of GLP experience, JOINN Laboratories was found to be fully compliant in the re-inspection.
The inspection results showed that the GLP system at JOINN Laboratories is fully compliant with the standards of the US FDA GLP. The US FDA GLP inspection team spoke highly of JOINN's quality management system. They believed JOINN has built a thorough quality system comparable to the best GLP institutions in USA.
JOINN Laboratories is the first Chinese CRO which submitted pre-clinical GLP reports to the US FDA. Due to the submissions, in July 2009, the US FDA inspected JOINN. With its excellent regulatory compliance, JOINN successfully passed the inspection, confirming that JOINN has attained international standards and is capable of carrying out pre-clinical safety assessment to support global registrations. After the inspection in 2009, JOINN continued to conduct drug safety assessments and have supported in filing more than 30 new drugs to the US FDA. All of them have passed and entered into clinical trials in the USA.
Up to now, JOINN Laboratories has become the Chinese CRO to submit the largest number of toxicology studies to the US FDA. The US FDA is inspecting JOINN to the same frequency as the domestic CROs in the USA. The result of the inspection marked the confirmation by US FDA on JOINN’s GLP regulatory compliance and JOINN’s outstanding capability for international service.
JOINN is continuously improving regulatory compliance and GLP management to ensure service quality and assist clients from all over the world to successfully register internationally. JOINN is now working hard to enter international markets and is ready to make further contributions to human health.