Overview

The purpose of the GLP(Good Laboratory Practice) is to ensure the reliability of the process and results of tests by establishing regulations(operating system, appropriate personnel and appropriate facilities) regarding non-clinical trials conducted to test the safety of pharmaceuticals, agrochemicals, cosmetics, chemicals and household goods.

QAU is an organization under the GLP regulations. It reviews the plans, implementation and reports of all safety tests. It also inspects whether the facilities and staff are in compliance with GLP regulations. The result of the inspection is reported to the study director and the facility manager in charge. The role of QAU is to assure the quality and reliability of the basic data and the final report of the safety test objectively from the perspective of a third party who is not involved in the test.

Service

- Domestic (FDA, Ministry of Environment, Rural Development Administration) GLP and Overseas OECD GLP Certification

- Inspection and reporting on facilities and personnel

- Inspection and reporting on the test plan

- Inspection and reporting on the test site

- Inspection and reporting on the basic data for test

- Inspection and reporting on the final report

- Preparation and storage of QAU related documents

- Government department GLP application and Regular survey of testing institutes

- Inspect SOPs and the complete test schedule

- Professional GLP training of new and existing employees

The role and responsibility of quality assurance in GLP Testing Institutions

We check the planning/implementation/reporting of the GLP tests conducted in accordance with the GLP regulations. We also guarantee the reliability of the basic data and final report achieved by the test, by ensuring that the facilities and staff are managed in accordance with the GLP regulations.

Flow of GLP test