Document Actions
Quality Assurance Unit
The Office of Research Compliance will designate quality assurance personnel to monitor the facilities, equipment, personnel, methods, practices, records, and controls to assure they conform to the GLP regulations, study protocols, and standard operating procedures. The QAU will perform periodic inspections of the quality system program. The QAU will conduct critical phase inspections and data audits at intervals sufficient to assure that GLP studies and related activities are conducted in accordance with the GLP regulations, the protocol, and SOPs (refer to TAMU SOPs for Quality Assurance).
Quality assurance personnel must be qualified to perform QA duties through experience, education, or a combination thereof as determined by testing facility management. GLP training and training on TAMU QAU SOP is required for all QAUs prior to providing services for GLP studies. QAU services provided by external sources for any GLP study must be approved by the Texas A&M testing facility management. Quality assurance personnel will remain entirely separate from and independent of the personnel engaged in the direction and conduct of a GLP study for which they provide QA services.