Study Director
Before starting a study, the facility's management should appoint a study director. This person should be either a scientist or a
professional with the necessary education, training, and experience to manage the study's technical aspects and interpret, analyze, document,
and report the study results.
Systems
Test protocol should be prepared and approved by an authorized
person. All data collected during experiments must be recorded accurately and
verified, including unanticipated responses. If any situation occurs that may
affect the quality and integrity of the study, it must be noted, and corrective
action must be taken and documented. All GLP regulations that apply to the
study must be followed and testing must be carried out as laid out in the
protocol. At the close of the study, all data, documents, samples, and final
reports must be archived safely.
Management
The test facility's management must ensure sure materials, facilities, resources, equipment, and personnel required for testing are available. It must also ensure that tests for identity, purity, strength, stability, and uniformity, as applicable, have been performed adequately. Personnel must understand the functions they are to perform. If deviations ared must be, the unit directly must report them to the study director; corrective actions must be taken and documented.
QA Unit
A quality assurance unit must be set up to be independent of the persons involved with the study. It must have written procedures and details of responsibilities and records to be maintained.
This unit must monitor that equipment, facilities,
personnel, practices, methods, records and controls match the GLP regulations.
It is this unit’s responsibility to have all information – a master schedule
sheet, protocols, etc – of the studies performed by the lab. The QA unit must
inspect the study regularly to verify the study's integrity, and these
inspections must be documented with signatures. Any problems that can
compromise the integrity of the study must be reported to the study director
and the management at once.
The QA unit must provide the study director with written status reports at regular intervals. Any problems and corrective actions must be clearly indicated. The unit must also ensure that no deviations from the standard operating procedures (SOPs) or protocol occur without duly documented authorization.
It is also the responsibility of the QA unit to review the
study report at the end and check that it gives an accurate description of the
methods and that the results being reported match the findings as per the raw
data generated in the study.
All QA documents must be made available for inspection by
the authorized FDA representative.