TetraQ operates within a quality framework in compliance with the following international standards:
- OECD Principles of Good Laboratory Practice (GLP)
- ISO 17025 (R&D) accreditation
- 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
17025 (R&D) accreditation recognises the technical competency of TetraQ's facility. TetraQ has been audited by clients and authorities.
TetraQ's accreditation includes accredited ELISA testing in its services to Australian and international biopharmaceutical organisations.
- TetraQ’s 21CFR11 compliant and validated state-of-the-art instruments and technologies include:
- Several Spark Symbiosis Robotic on-line Solid Phase Extraction (SPE) sample preparation systems directly coupled to 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
- Gas chromatography-mass spectrometry (GC-MS)
- ELISA instrumentation
- AB Sciex LightSight
- ProvantisTM GLP preclinical data management system
TetraQ's laboratories have secure access. All instruments, freezers, and IT-equipment are wired to monitoring and alert systems 24x7 and have uninterrupted.
TetraQ has environmentally controlled and monitored storage facilities to securely store your samples. Monitored temperature storage includes facilities at -80, -20, 4C, as well as adjustable sample stability chambers which can be monitored at required temperatures. TetraQ has ample experience in conducting analyses to assess the stability of the molecule(s) of interest over time as required by legislation from different jurisdictions including REACH, the European Community Regulation on chemicals and their safe use which deals with the Registration, Evaluation, Authorisation and Restriction of Chemical substances.