The quality assurance statement should clearly identify the study and include all the types of inspections that are relevant to the study (including inspections performed as part of a study phase(s)). Associated information should include the dates the inspections were performed and the dates inspection results were reported to management, the study director and if applicable the principal investigator. Some monitoring authorities will require the quality assurance statement to include confirmation that facility audits have been performed. The statement should confirm that the final report reflects the raw data and some monitoring authorities will require this fact to be clearly stated in the statement.
Verification of the study plan by QA personnel should be documented (see OECD Principles on Good Laboratory Practice, Doc. No. 1). This would also apply to study plan amendments. The GLP Principles do not formally require that these verifications are included in the quality assurance statement but this is often the case.
