Geneombio gets ISO IEC accreditation for biological testing plans US FDA registration
The Pune-based Geneombio Technologies Pvt Ltd (GTPL), a contract research organization providing customized DNA-based service in human and livestock health segments, received ISO/IEC 17025:2005 accreditation from the National Accreditation Board for Testing and Calibrating Laboratories (NABL) for biological testing in plants, animals and microbes.
The ISO/IEC 17025, first issued by the International Organization for Standardization in the year 1999 and later issued as ISO/IEC 17025:2005 by aligning its quality system words more closely with the 2000 version of ISO 9001, is the main standard used by testing and calibration laboratories. Strict adherence to the management and technical requirements, related to the operation and effectiveness of the quality management system with the lab and the competence of staff, methodology and test or calibration equipment, respectively. “This accreditation by NABL now would allow us to satisfy clients and research laboratories both in the private as well as public sector with international level of competence to in their high end genome analysis work programme for research or development of a diverse kind of biological tools.
The spectrum covered entails plants, animals and microbes thus imparting a sense of totality in the domains covered,” said Sachin Purohit, managing director, Genomebio. Moreover, the accreditation made the company closer to receive the Good Laboratory Practices (GLP) registration with the US Food and Drug Administration (USFDA). Some of the requirements of ISO/IEC 17025:2005 are similar to the GLP principles. “We are ultimately working to get the laboratory registered with the US FDA. Infact, we have started the application procedure with the US drug regulator a couple of months ago,” he informed.
The scope of the ISO/IEC 17025:2005 accreditation is considerably broad and vast. In the plant and agriculture products segment, modern methods of plant genome analysis including DNA fingerprinting, gene identification and cloning and few other similar aspects are enlisted even as, extraction, processing and analysis of animal and fish genome are enlisted in the animal products and molecular biology segment. The scope also includes various types of genotyping techniques, microbe genome analysis and gene expression studies. For instance, in diagnostic samples testing area, it includes various detection, identification and quantification of microbes and further, related downstream applications using various platforms involving conventional PCR, real time PCR and automated DNA sequencing technology, they added.
India has around 60 organizations accredited for ISO/IEC 17025 in the area of biological testing, out of which, the state of Maharashtra has 18 and the city of Pune has four including Geneombio. The company, with its strength in genome analysis, could serve a vast range of advanced molecular biology related activities, said Purohit. The company, which has its contract research services in molecular diagnostics, through conducting research and developing and manufacturing basic research kits for molecular biology laboratories, has also developed a HIV-I drug resistance assay recently.