１.Maintain copies of all approved study plans and Standard Operating Procedures in use in the test facility and have access to an up-to-date copy of the master schedule.
２.Verify that the study plan contains the information required for compliance with these Principles of GLP and documented the verification.
３.Conduct inspections to determine if all studies are conducted in accordance with these Principles of GLP. Inspections should also determine that study plans and SOP have been made available to study personnel and are being followed. Three types of inspection existed (Study, Facility and Process inspection).
４.Inspect the final reports to confirm that the methods, procedures, and observations are accurately and completely described, and that the reported results accurately and completely reflect the raw data of the studies.
５.Promptly report any inspection results in writing to management and to the Study Director.
６.Prepare and sign a statement, to be included with the final report, which specifies types of inspections and their dates, including the phase(s) of the study inspected, and the dates inspection results were reported to management and Study Director.
７. This statement would also serve to confirm that the final report reflects the raw data. |
