Our QAU has 18 full-time QA inspectors. Our inspectors are required to have professional training from SQA (Society of Quality Assurance) or CSQA (Chinese Society of Quality Assurance) and must have more than 5 years' relevant experience.
The head of QAU is a Registered Quality Assurance Professionals in Good Laboratory Practice (RQAP-GLP).
Following the GLP guidelines of FDA, OECD and CFDA, our QAU conducts rigorous inspections on study practices, records andinstruments. Upon discovery of a deviation, QAU would timely and properly report to related SD and the facility management.
It will then closely track the correction process until the problem is solved and the documentation is completed. QAU also conducts GLP inspection outside the facility, when needed.