In July, China’s Food and Drug Administration (CFDA) allowed self-inspections to occur for imported and local drugs. Although CFDA is allowing self-inspections for drugs, it will also be conducting random on-site inspections upon the reports that companies give them.
According to a recent Zachary Brennan article, “the self-inspections are also suppose to focus on the operation and maintenance of biological sample analysis and testing instruments., as well as the installment and operation of the audit trail module of data management software.”
To read the rest of Zachary Brennan’s article in outsourcing-pharma, click here.