Pharmaceutical industry and regulatory compliance have a long association, however, the development of each of these has been on a different stride. At first, pharmaceuticals came with focus on safety and efficacy of drugs. Recent FDA warning letters indicate increased focus on data integrity as a central concern of its inspection program. Many pharma manufacturers are outsourcing method developments, testing of raw materials and finished products to contract laboratories. It is a business imperative to treat them as an extension of their company to accelerate product development cycles, to put third party controls and to optimize return on their capital expenditure.
In the past, the role of third-party testing/contract labs was more of integrity, quality, impartiality and having required infrastructure and instrumentation. A quality management system with regulatory compliance is now fundamental and necessary component for any contract lab seeking regulatory approval. Best-in-class compliance is an opportunity for any independent lab looking for market differentiation. Demonstrating the integrity and security of lab data, records, results and information is paramount for a successful audit/inspection of any GMP regulated laboratory.
Our laboratory was inspected by US FDA in the past and found to be acceptable. Our expanded and upgraded pharma testing facilities have ISO17025 accreditation, OSHAS 18001 and ISO 9001 certifications, Department of Ayush and Drug control department approvals. Our most recent additions are ICP-MS and ICP-OES with auto samplers and AAS with graphite furnace and a fully compliant data management/archival system. At the beginning of 2014, we are proud to be serving customers from 25 different countries across five continents. We look forward to significantly increase our service footprint with increased focus on pharmaceutical and nutraceutical industries in this new financial year!