Project Overview: Assessing GLP Compliance and Quality Practices in China
CHA is launching a multi-company collaboration with partners from major pharmaceutical and biotechnology companies to jointly fund animal safety studies at leading preclinical safety evaluation facilities in China. The collaboration will efficiently and cost-effectively assess the true quality and ability of selected labs relative to western GLP requirements.
The primary objectives for this project are:
Execute a “proof of concept” evaluation of whether selected facilities can perform according to current global standards and therefore to definitively determine if they are ready to conduct this work for western clients
Provide “western industry” input to the SFDA on related regulations and policies based on consensus views gained from the experience with the studies
Give an opportunity for each collaboration member to establish productive long-term relationships with identified leading organizations
This project will be based on the placement of a comprehensive set of approximately five evaluative animal safety studies conducted over a 9 month interval at the China-based preclinical safety labs judged as most capable in CHA’s recently completed China Tox Evaluation project (see Background). Other laboratory facilities may be included in the evaluation based upon participating companies’ requests. These evaluation studies will cover a range of timeframes, expertise, and species. The conduct of these evaluation studies will be closely monitored on a regular basis by CHA to judge the lab’s ongoing performance; and outcomes will be carefully evaluated to ensure a complete and accurate assessment of each institution’s operating strengths and weaknesses.
This project is designed to be collaborative, and thus facilitated peer-to-peer discussion and learning across both member companies and the evaluated facilities, will be at the foundation of the entire process.