Quality Assurance Unit (QAU)
Farmacore assures that for all projects conducted under ISO 17025:2005, GLP and GMP regulations, the facilities, equipment, personnel, methods, practices, records and controls utilized during each study/project are in conformance with the applicable regulations.For each project, the Quality Assurance Unit is entirely independent of the personnel engaged in the direction and conduct of production.
- -Conduct GLP training courses.
- Maintain a Master Schedule sheet listing all studies conducted at FARMACORE under Good Laboratory Practice regulations.
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- -Assure that all aspects of a study/project necessary to maintain the integrity of that study/project are detailed by properly authorized standard operating procedures (SOPs) or in the project protocol.
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- -Periodically perform general inspections of FARMACORE GLP and GMP facilities, and maintain written and properly reviewed records of these inspections.
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- -Review the raw data generated during regulated study/project to assure that study/project procedures and experimental data were properly recorded and verified.
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- -Review final study reports to assure that each report accurately describes the methods and standard operating procedures utilized during the study, and that the reported results reflect the raw data of the study.
