41 Robust quality system designed to meet the global standards We have a robust governance process with periodic reviews at the operations level and by Corporate QA function and the management committee (CEO, COO and BU Heads). Our successful track record of completing regulatory audits without critical observations across all our facilities in the last two years proves to be a constant encouragement for our partners. We have had successful inspections by various regulatory agencies like USFDA, PMDA, COFEPRIS and WHO. We believe customer confidence in our quality system across development, technology transfer, and manufacturing is sustained, with 80% repeat customers. Quality Management Procedural Facility People/ Culture Robust Quality System Moving towards paperless quality environment with e-BPR/QMS documentation 100% track record of successful inspections by USFDA, PMDA, COFEPRIS, WHO etc 21 CFR part 11 Controls & DI Compliance GMP Pro & Electronic Laboratory Notebooks across the organization QMS Compliance Focus & Comprehensive Assessments Knowledge Management & continuous strengthening of Quality Management system Three pillars of quality management system As a part of continual improvement, we emphasize strengthening the Quality Management System’s three pillars, i.e., Procedure, People, and Facility. One of the approaches includes implementing various technologies and associated training through a dedicated platform in our Learning Management System (LMS). We proactively assess our systems against the current guidelines, 483 and warning letters issued to various pharmaceutical industries, and upgrade our quality system concurrently.
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