The Quality Assurance Unit

The IITRI Life Sciences Group's Quality Assurance Unit (QAU) was established to provide the utmost data quality and study integrity in accordance with Good Laboratory Practice (GLP) regulations.

In-Life Audits

Audits and inspections are performed throughout the facility to ensure that methods and practices conform to GLP standards. Studies are inspected during various critical phases for adherence to study protocol requirements as part of the GLP compliance program.

Records Management

The system of organization and retention of archives and other key records was designed by the QAU and IITRI management. At the completion of a study, all raw data, protocol samples, specimens and the final report are retained in IITRI's environmentally controlled archives. Access to the archives is limited to authorized personnel and the area is protected by a state-of-the-art fire suppression system.

Training

The QAU staff receives ongoing training in the application of and adherence to Good Laboratory Practice (GLP) regulations. Training records are maintained for all employees.

Data and Report Audits

Effective utilization of resources requires that the Quality Assurance program be designed to control data quality at the source. Each record is reviewed in process by appropriate QAU personnel. All study data, notebooks and files are audited by the QAU to ensure compliance to the protocol, standard operating procedures and GLP regulations. Final reports are audited to ensure that they accurately reflect the raw data and provide a description of the experimental methods, observations and results. At final review, the QAU prepares and signs a Quality Assurance Statement that is included with the final report.

Experience

The experienced QAU staff brings technical expertise to the studies audited. The QAU has experience monitoring studies designed to comply with U.S. Food and Drug Administration (FDA) regulations and U.S. Environmental Protection Agency (EPA) guidelines established under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) or the Toxic Substance Control Act (TSCA). The QAU also has knowledge of international regulations including those set forth by the Organization for Economic Cooperation and Development (OECD) and guidelines for Japan's testing of drugs (MHW) and agrichemicals (MAFF).