National GLP monitoring authorities may request information relating to the types of QA inspections conducted and the dates they were performed and reported to management. They may also request the names of the QA auditors who performed specific activities so that their training records can be reviewed. However, QA inspection findings will not normally be examined by inspectors as this is likely to have a negative impact on the way in which some QA personnel report findings. Nevertheless, some national monitoring authorities may occasionally require access to the contents of inspection reports in order to verify the adequate functioning of QA or to verify that management has received and acted upon reports from QA concerning problems that are likely to seriously affect the quality or integrity of the facility or a study. Under no circumstances should QA reports be inspected as an easy way to identify inadequacies within the facility or problems associated with a specific study.
Compliance monitoring authority inspectors will need to verify the effectiveness of QA activities as part of the inspection of QA. In order to do this it is highly likely that they will routinely review QA procedures and other supporting records (with the exception of the inspection report). These documents will be used to verify key requirements including the independence of QA from study specific activities, that critical study phases are monitored in accordance with the facility’s policies and that the frequency of audits is sufficient etc.
