The GLPS state at 40 CFR 160.35(a) that a testing facility shall have a Quality Assurance Unit (QAU) that shall monitor each study to assure management that the facilities, equipment, personnel, methods, practices, records, and controls are in conformance with the GLPS. The GLPS further state at 40 CFR 160.35(b)(3) that the QAU shall inspect each study at intervals adequate to ensure the integrity of the study.
Clearly, the QAU must conduct inspections adequate to provide the assurances required at 40 CFR 160.35(a) and, in the course of so doing, must inspect each study at least once. All parameters must be verified adequate for each site, but it is acceptable to use inspections conducted during other studies to provide necessary assurances. It is also acceptable to use inspections conducted when no study is in progress to assure that methods, personnel, etc. at a particular site are in conformance with GLPS. However, acceptability of such inspections is contingent on assuring that the facilities, personnel, methods, etc., which are inspected are representative of those used in the study. Note that it is necessary to reinspect facilities periodically to account for changes in personnel, equipment etc. Finally, no matter how complete QAU inspectional coverage is regarding the sites involved in a study, it is still necessary to conduct at least one inspection of study activities while the study is in progress.
Is it acceptable to inspect study-related procedures at a time other than when the study is ongoing?
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