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Assessing GLP Compliance and Quality Practices in China
Background
About Collaborative Projects
Current Collaborative Projects - Enrollment Open
Evaluating Preclinical Cardio-Toxicity Assessment Tools
Leveraging Biomarker & Translational Research in China
Assessing GLP Compliance and Quality Practices in China
Exploiting Legacy Safety Studies
Assessing the Asian Supply Chain of Non-Human Primates (NHPs)
Case Studies of Past CHA Projects
Background
This project is the successor project to the recently completed
China Tox Evaluation project
. That project successfully evaluated physical facilities, animal care & use practices, GLP maturity, etc. of ten of the top rated pre-clinical safety facilities in China. That evaluation demonstrated the approximate state of GLP compliance and readiness, but by design could not demonstrate the overall operating effectiveness and quality practices of these institutions. Thus, this next stage will focus on answering the question of whether these facility’s everyday work practices are delivering a safety package that can be utilized to support a regulatory finding in the west. In addition, a closely monitored series of evaluation studies provides an educational and mentoring opportunity to help these facilities attain and maintain globally acceptable laboratory operating practices. With this assistance, labs should be able to more rapidly expand capacity and participating companies will establish relationships from which they will sooner be able to derive benefits from operating in China.
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