The Pune-based Geneombio Technologies Ltd, a contract research firm in the field of DNA-based testing services, is lining up for a set of regulatory filings to make its laboratory eligible to carry out more tests in compliance with national and international regulatory standards.

The company, which has recently received ISO/IEC 17025: 2005 for complying with the international standards for management and testing requirements, is now planning to get the Good Laboratory Practices (GLP) compliance from the National GLP Compliance Monitoring Authority (NGCMA).

GLP certification seeks to ensure the non-hazardous nature of the pharma, veterinary and cosmetic product at the plant and to follow the guidelines conceived by the Organisation for Economic Co-operation and Development (OECD).

“National GLP Compliance Monitoring Authority was established by the Department of Science & Technology, Government of India, with the approval of the Union Cabinet on April 24, 2002. Compliance with this standard will open us more opportunity to the member countries of OECD,” said Sachin Purohit, managing director, Geneombio. The GLP-compliance Certification, which is based on the managerial and technical level quality of standards, is valid for a period of three years.

The NGCMA issues GLP on various fields including physical-chemical testing, toxicity studies, mutagenicity studies, environmental toxicity studies on aquatic and terrestrial organisms, studies on behaviour in water, soil and air, bio-accumulation, residue studies, studies on effects on mesocosms and natural ecosystems, analytical and clinical chemistry testing including other areas of laboratory testing services

At present, almost 15 facilities run by major pharma companies like Ranbaxy Laboratories, Dr Reddy's Laboratories, Zydus Research Centre, Advinus Therapeutics, Reliance Life Sciences and Orchid Research Lab along with government run laboratories like the National Toxicology Centre under the National Institute of Pharmaceutical Education and Research (NIPER), Mohali, are accredited by the NGCMA.

Simultaneously, the company is filing documents with the National Accreditation Board for Testing and Calibrating Laboratories (NABL) for ISO 15189:2007, which specifies requirements for quality and competence particular to medical laboratories. If received, the certificate would accredit the company as an eligible laboratory facility to issue clinical reports on any pathology tests.

ISO 15189:2007 is an accreditation used by medical laboratories in developing their quality management systems and assessing their own competence, and for use by accreditation bodies in confirming or recognising the competence of medical laboratories.

The company is planning to apply for these accreditation within next couple of months, and has expectations in business revenue from these services eventually, said Purohit.