JOINN (Suzhou) Successfully Passed the FDA GLP Inspection
2016-08-12
JOINN Laboratories (Suzhou) hosted a most successful inspection visit from the US FDA in early August 2016. The visit involved review of data from studies selected by the FDA team and notified to JOINN at the time, general review of the extensive, industry leading facilities, and evaluation of all GLP procedures and systems. JOINN use their dual language capability to report studies in both English and Chinese to CFDA and US FDA.
According to Dr Dylan Yao, Senior VP and CSO, this recent inspection added to the endorsement of GLP compliance that JOINN already hold. The FDA have visited JOINN (Beijing) on two previous occasions and have endorsed the high level of compliance there. This US FDA inspection at Suzhou follows the acceptance of JOINN into the Polish OECD monitoring programme in 2015 and is yet another indication of the ability of JOINN to meet the regulatory needs of an international client base.
Dylan says “whilst it is taken as read that GLP compliance and acceptance of data by international authorities is a price of entry to the Preclinical CRO market, we really value the insights and observations made by those who audit our performance. Or course, GLP isn’t our only quality standard; AAALAC underpins our Commitment to Animal Care and goes hand-in-hand with GLP and the associated good science. No lab is ever perfect but at JOINN we aim high and continuously monitor and refine our operations; we always welcome an external perspective on how well we are doing.”
