TetraQ operates within a quality framework in compliance with the following international standards:
- OECD Principles of Good Laboratory Practice (GLP)
- FDA Good Laboratory Practice for Nonclinical Laboratory Studies (21CFR58)
- FDA Electronic Records; Electronic Signatures (21CFR11)
GLP compliance ensures that data will be accepted for international regulatory review e.g. FDA. This is a consequence of the Australian GLP monitoring body, NATA (National Association of Testing Authorities), being a signatory to an international agreement for the mutual acceptance of data. ISO
TetraQ has been audited by clients and authorities.
- TetraQ’s 21CFR11 compliant and validated state-of-the-art instruments and technologies include:
- Liquid chromatograph-triple quadrupole mass spectrometry (LC-MS/MS) instrumentation, i.e. AB Sciex analysers: API 5500 Qtrap, API 4000 Qtrap, API 4000, API 3200
- High performance liquid chromatography (HPLC) with a full range of detectors
- Spark Symbiosis Robotic on-line Solid Phase Extraction (SPE) sample preparation systems directly
- Tecan ELISA Readers
- Mesoscale Discovery ECL
- WinNonlin software
- ProvantisTM GLP preclinical data management system for toxicology
TetraQ's laboratories have secure access. All instruments, freezers, and IT-equipment are wired to monitoring and alert systems 24x7 with UPS backup power on key instruments.
TetraQ has environmentally controlled and monitored storage facilities to securely store your samples. Monitored temperature storage includes facilities at -80, -20, 4°C.