Gentronix Limited has announced its strategic intention to offer regulatory genotox assays, and is currently working towards ‘Good Laboratory Practice’ (GLP) compliance.
GLP is a quality system of management controls for research laboratories to ensure the quality and reliability of test data from non-clinical safety studies. Specifically, these are studies to examine the properties and/or safety of chemical compounds, extracts and mixtures, where data are intended for submission to regulatory authorities in the fields of pharmaceuticals, agrochemicals, veterinary medicines, industrial chemicals, cosmetics, food and feed additives and biocides.
Test facilities that conduct regulatory studies must, by law, join the compliance monitoring programme. This process begins, once all of the appropriate systems, facilities, and qualified personnel are in place, with an application to the GLP Monitoring Authority (GLPMA).
This application is reviewed by the GLPMA and the company’s systems, facilities and personnel are audited. If successful, the company is awarded a ‘Statement of GLP Compliance’, and is permitted to offer GLP services. This certification is subject to continuing compliance which is verified by periodic re-auditing.
As specialists in genotoxicity, Gentronix intends to initially offer GLP compliant Ames and in vitro micronucleus (MNT) tests as prescribed in the “OECD Guidelines for the Testing of Chemicals, Section 4: Health Effects” tests 471: Bacterial Reverse Mutation and 487: In Vitro Mammalian Cell Micronucleus Test.
Gentronix Chairman and CEO John Nicholson said “While this is a major investment for Gentronix, it is also an important strategic move which will allow us to offer a wider spectrum of genotoxicity testing from early screening through mechanism studies to final regulatory submission, thereby positioning ourselves as the “go-to” genotox company. Experienced Study Directors have already been recruited and we are continuing to recruit staff with GLP experience.”