For an active study, QA’s primary responsibility is to assure test facility management that studies conform to GLP regulations. This includes verification that the data submitted are an accurate reflection of the results and that the agreed-upon test protocol was followed.
A principal way QA does this is by auditing studies as they are actively being conducted. To be compliant, a study must receive at least one active-phase audit. During these audits, QA verifies that the study protocol, as well as any SOPs, are followed. At Microchem, various aspects of the study’s quality are observed, recorded, and challenged during active-phase audits. For example, the QAU determines whether the performing scientist has adequate training that is properly logged and whether the equipment used in the test has been certified to traceable standards.
A second way the QA group ensures GLP compliance is by auditing the study report. Here, QA is ensuring the report correctly describes the methods used during study conduct and that the data is accurately reported; this traceability of results is a key component of GLP testing. Microchem Laboratory performs a minimum of one report audit per study; however, most studies receive two report audits to ensure reports are produced at the highest level of quality. Save