JOINN Laboratories (Beijing) Successfully Passed US FDA GLP Inspection
2009-07-21
During the summer of 2009, for the first time, US FDA sent officials to inspect GLP institutions in China. JOINN Laboratories (Beijing), a native-Chinese research institution specializing in safety assessment of drugs and bio-products, was inspected from July 13th, to July 17th 2009 and successfully passed.
GLP inspections, originated from the USA, normally took place prior to global drug registrations and have been regarded as an indispensable step to ensure the drug's safety. The USA initiated the GLP regulations program in 1976. From then on, all new drugs registered in the USA must pass FDA GLP inspections. US GLP regulations is are highly regarded among global regulatory administrations: countries including Japan, Korea and many European countries issued their own GLP regulations and inspections. CFDA issued GLP regulations in 1999 and carried out GLP accreditations, droving the GLP development in China. GLP inspection by the US FDA is the strictest of all around the world. Drug assessment institutions within China treat passing GLP inspection as the ultimate goal of regulation certification.
FDA GLP inspection is different from the inspections required to support drug development and manufacturing (Bioequivalence, GMP, GCP, and etc.). FDA GLP inspection covers regulations, pharmacology, toxicology, chemistry, veterinary support, information technology and archiving, making it a comprehensive assessment of an institution's capabilities. The inspection team carefully inspected JOINN's facility management system, the quality assurance unit, JOINN's study directors, scientists, technicians, JOINN's laboratory animal management system, as well as JOINN's experimental implementation and data analysis. FDA GLP inspection team spoke highly of JOINN's GLP institution, confirmed that there is no violation of GLP regulations.
Ms. Yuxia Feng, chairman and CEO of JOINN Laboratories commented on JOINN's passing FDA GLP inspection: "JOINN Laboratories is the only private GLP institution among the earliest 35 CFDA-accredited institutions in China. We have recruited returnee PhDs as well as local talents with the help of relevant government departments. Our employees strictly adhere to GLP regulations, whilst providing state-of-the-art services to our clients. The result of the US FDA inspection not only recognizes the hard work of JOINN but also confirms the quality of Chinese GLP institutions after many years of GLP implementations by relevant government departments. JOINN's first pass of US FDA GLP inspection also demonstrates that the research data in China is recognized by the US FDA."