Inspector Dr. Stephen Hansen from US FDA proceeded a five-day long GLP inspection to the National Safety Evaluation Research Center of New Drug (Shenyang) from July 2nd to July 6th. The inspector performed a series of detailed inspections on the research projects, such as organization, stuff, SOP, experimental facility, archive files, quality control system etc.
Through the inspections for almost a week, Dr. Hansen was very satisfied with the result and spoke highly of the positive teamwork of the center. He considered that the GLP system of the center conformed to the US FDA GLP regulation demand.
The successful passage shows that our lab management and operating level obtains the recognition of US FDA. It’s another milestone since the first OECD GLP authentication in 2012.
The center has developed rapidly on new drug preclinical safety evaluation since the CFDA GLP in 2003. Supporting by the national medicine major special projects platform, the center can offer to the enterprises a one-stop service including safety evaluation of traditional Chinese medicine, new drug, biological drug and clinical sample test. The US FDA inspection made the center serve clients preferably.