The Good Laboratory Practice Regulations 1999

Quality assurance programme U.K.

4.—(1) Purpose: to determine whether the mechanisms used to assure management that regulatory studies are conducted in accordance with the principles of good laboratory practice are adequate.

(2) The head of the quality assurance unit should be asked to demonstrate the systems and methods of quality assurance inspection and monitoring of studies, and the system for recording observations made during quality assurance monitoring. Inspectors should check—

• —the qualifications of the head of quality assurance, and of all quality assurance staff,

• —that the quality assurance unit functions independently from the staff involved in the studies,

• —how the quality assurance unit schedules and conducts inspections, how it monitors identified critical phases in a study, and what resources are available for quality assurance inspections and monitoring activities,

• —that where studies are of such short duration that monitoring of each study is impracticable, arrangements exist for monitoring on a sample basis,

• —the extent and depth of quality assurance monitoring during the practical phases of the study,

• —the extent and depth of quality assurance monitoring of routine test facility operation,

• —the quality assurance procedure for checking the final report to ensure its agreement with the raw data,

• —that management receives reports from quality assurance concerning problems likely to affect the quality or integrity of a study,

• —the actions taken by quality assurance when deviations are found,

• —the quality assurance role, if any, if studies or parts of studies are done in contract laboratories,

• —the part played, if any, by quality assurance in the review, revision and up-dating of standard operating procedures.